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    Clinical Trial Results:
    A Phase 1b/2a Pilot Randomized Study to Evaluate the Safety and Tolerability of Autologous T-Cells Expressing Enhanced TCRs (T-Cell Receptors) Specific for NY-ESO-1/LAGE-1a (GSK3377794) Alone, or in Combination with Pembrolizumab in HLA-A2+ Participants with NY-ESO-1- or LAGE-1a-Positive Advanced or Recurrent Non-Small Cell Lung Cancer

    Summary
    EudraCT number
    		 2018-003949-42
    Trial protocol
    		 GB   NL   ES  
    Global end of trial date
    04 Nov 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Jul 2023
    First version publication date
    08 Jul 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    208471
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03709706
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    980 Great West Road, Brentford, Middlesex, United Kingdom, TW8 9GS
    Public contact
    GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    24 Jan 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Nov 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the safety and tolerability of autologous genetically modified T-cells (GSK3377794) in human leukocyte antigen (HLA) HLA-A*02:01, HLA-A*02:05 and/or HLA-A*02:06 positive participants with NY-ESO-1 and/or LAGE-1a positive advanced NSCLC alone [Arm A] or GSK3377794 in combination with pembrolizumab in participants with NSCLC with patients lacking or patients with actionable genetic aberrations.
    Protection of trial subjects
    Not applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 Dec 2018
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 15 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 10
    Country: Number of subjects enrolled
    Spain: 3
    Country: Number of subjects enrolled
    United States: 21
    Worldwide total number of subjects
    34
    EEA total number of subjects
    13
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    20
    From 65 to 84 years
    14
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Open-label study that evaluated the safety and tolerability of autologous T-cells expressing enhanced T-cell receptors (TCRs) that were specific for New York esophageal squamous cell carcinoma (NY-ESO)-1 and/or Cancer testis antigen 2 (LAGE-1a) (GSK3377794, Lete-cel) in participants with Advanced or Recurrent Non-Small Cell Lung Cancer.

    Pre-assignment
    Screening details
    		 34 participants with Advanced/Recurrent NSCLS with Human Leukocyte Antigen (HLA)-A02:01, HLA-A02:05,and/or HLA-A*02:06 were enrolled, out of which 13 received Lete-cel infusion. The study was terminated due to reasons pertaining to feasibility. As a result of early termination, no participants were assigned to Arm B, thus no analysis was performed

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A: Lete-cel monotherapy
    Arm description
    		 Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T- cell receptors (TCR) specific for NY-ESO-1/LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel. Participants who had disease progression within 25 weeks of Lete-cel infusion were offered therapy with Pembrolizumab following benefit-risk evaluation. Pembrolizumab 200 mg was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until subsequent disease progression or intolerable toxicity. Pembrolizumab therapy was not allowed if disease progression occurred post 25 weeks of Lete-cel infusion.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lete-cel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T- cell receptors (TCR) specific for NY-ESO-1/LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel. Participants who had disease progression within 25 weeks of Lete-cel infusion were offered therapy with Pembrolizumab following benefit-risk evaluation. Pembrolizumab 200 mg was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until subsequent disease progression or intolerable toxicity. Pembrolizumab therapy was not allowed if disease progression occurred post 25 weeks of Lete-cel infusion.

    Investigational medicinal product name
    Fludarabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T-cell receptors (TCR) specific for NY-ESO-1 /LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel followed by pembrolizumab 200 mg starting on Day 22 (Week 4 Day 1). Pembrolizumab was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until disease progression, whichever occurred first.

    Investigational medicinal product name
    Cyclophosphamide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T-cell receptors (TCR) specific for NY-ESO-1 /LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel followed by pembrolizumab 200 mg starting on Day 22 (Week 4 Day 1). Pembrolizumab was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until disease progression, whichever occurred first.

    Arm title
    		 Arm C: Lete-cel + pembrolizumab
    Arm description
    		 Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T-cell receptors (TCR) specific for NY-ESO-1 /LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel followed by pembrolizumab 200 mg starting on Day 22 (Week 4 Day 1). Pembrolizumab was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until disease progression, whichever occurred first.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lete-cel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T-cell receptors (TCR) specific for NY-ESO-1 /LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel followed by pembrolizumab 200 mg starting on Day 22 (Week 4 Day 1). Pembrolizumab was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until disease progression, whichever occurred first.

    Investigational medicinal product name
    Pembrolizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T-cell receptors (TCR) specific for NY-ESO-1 /LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel followed by pembrolizumab 200 mg starting on Day 22 (Week 4 Day 1). Pembrolizumab was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until disease progression, whichever occurred first.

    Investigational medicinal product name
    Cyclophosphamide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T-cell receptors (TCR) specific for NY-ESO-1 /LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel followed by pembrolizumab 200 mg starting on Day 22 (Week 4 Day 1). Pembrolizumab was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until disease progression, whichever occurred first.

    Investigational medicinal product name
    Fludarabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T-cell receptors (TCR) specific for NY-ESO-1 /LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel followed by pembrolizumab 200 mg starting on Day 22 (Week 4 Day 1). Pembrolizumab was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until disease progression, whichever occurred first.

    Number of subjects in period 1
    		Arm A: Lete-cel monotherapy Arm C: Lete-cel + pembrolizumab
    Started
    20
    14
    Intent-to-Treat (ITT) Population
    20
    14
    Modified - Intent to Treat Population
    7
    6
    No Treatment
    13
    8
    Completed
    3
    3
    Not completed
    17
    11
         Physician decision
    14
    8
         Consent withdrawn by subject
    2
    1
         Adverse event, non-fatal
    -
    1
         Death Prior to Lete-Cel Infusion
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm A: Lete-cel monotherapy
    Reporting group description
    		 Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T- cell receptors (TCR) specific for NY-ESO-1/LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel. Participants who had disease progression within 25 weeks of Lete-cel infusion were offered therapy with Pembrolizumab following benefit-risk evaluation. Pembrolizumab 200 mg was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until subsequent disease progression or intolerable toxicity. Pembrolizumab therapy was not allowed if disease progression occurred post 25 weeks of Lete-cel infusion.

    Reporting group title
    Arm C: Lete-cel + pembrolizumab
    Reporting group description
    		 Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T-cell receptors (TCR) specific for NY-ESO-1 /LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel followed by pembrolizumab 200 mg starting on Day 22 (Week 4 Day 1). Pembrolizumab was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until disease progression, whichever occurred first.

    Reporting group values
    		 Arm A: Lete-cel monotherapy Arm C: Lete-cel + pembrolizumab Total
    Number of subjects
    		 20 14 34
    Age categorical
    Units: Subjects
        19-64 years
    		 11 9 20
        >=65 years
    		 9 5 14
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 62.1 ( 8.90 ) 59.4 ( 10.25 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 8 9 17
        Male
    		 12 5 17
    Race/Ethnicity, Customized
    Units: Subjects
        Asian
    		 0 1 1
        White
    		 19 12 31
        Unknown or Not Reported
    		 1 1 2

    End points

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    End points reporting groups
    Reporting group title
    Arm A: Lete-cel monotherapy
    Reporting group description
    		 Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T- cell receptors (TCR) specific for NY-ESO-1/LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel. Participants who had disease progression within 25 weeks of Lete-cel infusion were offered therapy with Pembrolizumab following benefit-risk evaluation. Pembrolizumab 200 mg was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until subsequent disease progression or intolerable toxicity. Pembrolizumab therapy was not allowed if disease progression occurred post 25 weeks of Lete-cel infusion.

    Reporting group title
    Arm C: Lete-cel + pembrolizumab
    Reporting group description
    		 Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T-cell receptors (TCR) specific for NY-ESO-1 /LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel followed by pembrolizumab 200 mg starting on Day 22 (Week 4 Day 1). Pembrolizumab was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until disease progression, whichever occurred first.

    Primary: Number of participants with treatment-emergent adverse events (AEs) and serious adverse events (SAEs)

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    End point title
    		 Number of participants with treatment-emergent adverse events (AEs) and serious adverse events (SAEs) [1]
    End point description
    An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. AEs which start or worsen on or after T-cell infusion are defined as treatment-emergent. Modified Intent-to-Treat (mITT) population included all participants who received Lete-cel infusion.
    End point type
    Primary
    End point timeframe
    Up to approximately 10 months
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The primary endpoint of the study was planned to analyses with only descriptive statistics. Hence, no statistical analysis were performed.
    End point values
    		 Arm A: Lete-cel monotherapy Arm C: Lete-cel + pembrolizumab
    Number of subjects analysed
    7
    6
    Units: Participants
        AEs
    7
    6
        SAEs
    5
    3
    No statistical analyses for this end point

    Primary: Number of participants with treatment-emergent adverse events of Special Interest (AESI)

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    End point title
    		 Number of participants with treatment-emergent adverse events of Special Interest (AESI) [2]
    End point description
    AESI included cytokine release syndrome (CRS), pneumonitis/pneumonia, graft vs host disease (GvHD), guillain barre syndrome (GBS) or acute inflammatory demyelinating polyneuropathy (AIDP), pancytopenia/aplastic anemia (including analysis of all hematopoietic cytopenias), immune effector cell-associated neurotoxicity syndrome (ICANS) and treatment-related inflammatory response at tumor site. AEs which start or worsen on or after T-cell infusion are defined as treatment-emergent. mITT population.
    End point type
    Primary
    End point timeframe
    Up to approximately 10 months
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The primary endpoint of the study was planned to analyses with only descriptive statistics. Hence, no statistical analysis were performed.
    End point values
    		 Arm A: Lete-cel monotherapy Arm C: Lete-cel + pembrolizumab
    Number of subjects analysed
    7
    6
    Units: Participants
    6
    6
    No statistical analyses for this end point

    Primary: Number of participants with treatment-emergent adverse events and serious adverse events based on maximum severity grades

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    End point title
    		 Number of participants with treatment-emergent adverse events and serious adverse events based on maximum severity grades [3]
    End point description
    An AE is any untoward medical occurrence in a clinical investigation, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. AEs which start or worsen on or after T-cell infusion are defined as treatment-emergent. Severity was reported during study and was assigned a grade according to the NCI-CTCAE. AEs and SAEs severity were graded on a 5-point scale as: 1 = mild; discomfort noticed, 2 = moderate discomfort, 3 = severe; inability to work or perform normal daily activity, 4 = life-threatening consequences and 5 = death related to AE. mITT population.
    End point type
    Primary
    End point timeframe
    Up to approximately 10 months
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The primary endpoint of the study was planned to analyses with only descriptive statistics. Hence, no statistical analysis were performed.
    End point values
    		 Arm A: Lete-cel monotherapy Arm C: Lete-cel + pembrolizumab
    Number of subjects analysed
    7
    6
    Units: Participants
        AEs, Grade 2
    1
    0
        AEs, Grade 3
    1
    3
        AEs, Grade 4
    5
    2
        AEs, Grade 5
    0
    1
        SAEs, Grade 3
    4
    2
        SAEs, Grade 4
    1
    0
        SAEs, Grade 5
    0
    1
    No statistical analyses for this end point

    Primary: Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by investigator assessment

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    End point title
    		 Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by investigator assessment [4]
    End point description
    Overall response rate (ORR) defined as the percentage of participants with a complete response (CR) or partial response (PR) via investigator assessment per RECIST (Response Evaluation Criteria in Solid Tumors Criteria) v1.1 relative to the total number of participants in the analysis population. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeters (mm). Confidence intervals (CI) were calculated using the exact (Clopper-Pearson) method. mITT population.
    End point type
    Primary
    End point timeframe
    Up to approximately 10 months
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The primary endpoint of the study was planned to analyses with only descriptive statistics. Hence, no statistical analysis were performed.
    End point values
    		 Arm A: Lete-cel monotherapy Arm C: Lete-cel + pembrolizumab
    Number of subjects analysed
    7
    6
    Units: Percentage of Participants
        number (confidence interval 95%)
    0 (0 to 41)
    0 (0 to 45.9)
    No statistical analyses for this end point

    Primary: Number of Participants AEs leading to dose delays

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    End point title
    		 Number of Participants AEs leading to dose delays [5]
    End point description
    An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with AEs leading to dose delays were summarized. Modified Intent-to-Treat (mITT) population.
    End point type
    Primary
    End point timeframe
    Up to approximately 10 months
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The primary endpoint of the study was planned to analyses with only descriptive statistics. Hence, no statistical analysis were performed.
    End point values
    		 Arm A: Lete-cel monotherapy Arm C: Lete-cel + pembrolizumab
    Number of subjects analysed
    7
    6
    Units: Participants
    1
    1
    No statistical analyses for this end point

    Secondary: Progression-free survival (PFS) per RECIST version 1.1 by investigator assessment

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    End point title
    		 Progression-free survival (PFS) per RECIST version 1.1 by investigator assessment
    End point description
    Progression free survival was defined as the interval between the date of T cell infusion and the earliest date of disease progression or death due to any cause. Progressive disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. PFS based on responses assessed by investigator per RECIST v1.1 is presented. Kaplan-Meier Median and 95% confidence intervals are presented. Confidence intervals were calculated using the Brookmeyer-Crowley method. mITT population.
    End point type
    Secondary
    End point timeframe
    Up to approximately 10 months
    End point values
    		 Arm A: Lete-cel monotherapy Arm C: Lete-cel + pembrolizumab
    Number of subjects analysed
    7
    6
    Units: Months
        median (confidence interval 95%)
    5.32 (1.45 to 5.52)
    1.48 (0.62 to 2.83)
    No statistical analyses for this end point

    Secondary: Disease control rate (DCR) per RECIST version 1.1 by investigator assessment

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    End point title
    		 Disease control rate (DCR) per RECIST version 1.1 by investigator assessment
    End point description
    DCR was defined as the percentage of participants with a confirmed complete response (CR), partial response (PR), or stable disease (SD) for at least 6 months as per RECIST v1.1. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeters (mm). SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Confidence intervals (CI) were calculated using the exact (Clopper-Pearson) method. mITT population.
    End point type
    Secondary
    End point timeframe
    Up to approximately 10 months
    End point values
    		 Arm A: Lete-cel monotherapy Arm C: Lete-cel + pembrolizumab
    Number of subjects analysed
    7
    6
    Units: Percentage of Participants
        number (confidence interval 95%)
    0 (0 to 41)
    0 (0 to 45.9)
    No statistical analyses for this end point

    Secondary: Time to Cmax (Tmax) of lete-cel

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    End point title
    		 Time to Cmax (Tmax) of lete-cel
    End point description
    Tmax was defined as time to reach peak cell expansion during the study. Blood samples were collected for analysis of Tmax of lete-cel. Pharmacokinetic (PK) population.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 15
    End point values
    		 Arm A: Lete-cel monotherapy Arm C: Lete-cel + pembrolizumab
    Number of subjects analysed
    7
    6
    Units: Days
        median (full range (min-max))
    3 (1 to 15)
    7.9 (1 to 15)
    No statistical analyses for this end point

    Secondary: Duration of response (DOR) per RECIST version 1.1 by investigator assessment

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    End point title
    		 Duration of response (DOR) per RECIST version 1.1 by investigator assessment
    End point description
    Duration of response was defined as the interval between the initial date of confirmed response (PR/CR) and the date of progressive disease or death among participants with a confirmed response per RECIST 1.1. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeters. mITT population. Only participants with CR or PR were included in the analysis.
    End point type
    Secondary
    End point timeframe
    Up to approximately 10 months
    End point values
    		 Arm A: Lete-cel monotherapy Arm C: Lete-cel + pembrolizumab
    Number of subjects analysed
    0 [6]
    0 [7]
    Units: Months
        median (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [6] - No participant achieved CR or PR, hence the number of participants analyzed is 0.
    [7] - No participant achieved CR or PR, hence the number of participants analyzed is 0.
    No statistical analyses for this end point

    Secondary: Time to response (TTR) per RECIST version 1.1 by investigator assessment

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    End point title
    		 Time to response (TTR) per RECIST version 1.1 by investigator assessment
    End point description
    Time to response was defined as the interval of time between the date of T-cell infusion and the first documented evidence of the confirmed response (PR or CR), in the subset of participants with a confirmed PR or CR as their best confirmed overall response. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 mm. mITT population. Only participants with CR or PR were included in the analysis.
    End point type
    Secondary
    End point timeframe
    Up to approximately 10 months
    End point values
    		 Arm A: Lete-cel monotherapy Arm C: Lete-cel + pembrolizumab
    Number of subjects analysed
    0 [8]
    0 [9]
    Units: Months
        median (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [8] - No participant achieved CR or PR, hence the number of participants analyzed is 0.
    [9] - No participant achieved CR or PR, hence the number of participants analyzed is 0.
    No statistical analyses for this end point

    Secondary: Maximum transgene expansion (Cmax) of lete-cel

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    End point title
    		 Maximum transgene expansion (Cmax) of lete-cel
    End point description
    Cmax was defined as peak cell expansion during the study. Blood samples were collected for analysis of Cmax of lete-cel. Pharmacokinetic (PK) population included all participants in the mITT population from whom at least one PK sample was obtained, analyzed, and was measurable.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 15
    End point values
    		 Arm A: Lete-cel monotherapy Arm C: Lete-cel + pembrolizumab
    Number of subjects analysed
    7
    6
    Units: Copies per microgram genomic DNA
        geometric mean (geometric coefficient of variation)
    155712.1398 ( 55.21519 )
    127343.0679 ( 34.95574 )
    No statistical analyses for this end point

    Secondary: Area under the plasma concentration-time curve to day 28 (AUC0-28d) of lete-cel

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    End point title
    		 Area under the plasma concentration-time curve to day 28 (AUC0-28d) of lete-cel
    End point description
    Area under the cell expansion-time curve from first T-cell infusion to Day 28. Blood samples were collected to measure AUC (0-28 days). Pharmacokinetic (PK) population.
    End point type
    Secondary
    End point timeframe
    Up to 28 days
    End point values
    		 Arm A: Lete-cel monotherapy Arm C: Lete-cel + pembrolizumab
    Number of subjects analysed
    7
    6
    Units: Days*copies per microgram genomic DNA
        geometric mean (geometric coefficient of variation)
    1646416.5835 ( 109.45757 )
    1565617.646 ( 46.16918 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
    Adverse event reporting additional description
    All cause mortality, SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 V25.1
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Arm A: Lete-cel monotherapy
    Reporting group description
    		 Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T- cell receptors (TCR) specific for NY-ESO-1/LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel. Participants who had disease progression within 25 weeks of Lete-cel infusion were offered therapy with Pembrolizumab following benefit-risk evaluation. Pembrolizumab 200 mg was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until subsequent disease progression or intolerable toxicity. Pembrolizumab therapy was not allowed if disease progression occurred post 25 weeks of Lete-cel infusion.

    Reporting group title
    No Treatment
    Reporting group description
    		 Participants who underwent leukapheresis but did not go on to receive lymphodepletion chemotherapy or T-cell infusion.

    Reporting group title
    Arm C: Lete-cel + pembrolizumab
    Reporting group description
    		 Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T-cell receptors (TCR) specific for NY-ESO-1 /LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel followed by pembrolizumab 200 mg starting on Day 22 (Week 4 Day 1). Pembrolizumab was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until disease progression, whichever occurred first.

    Serious adverse events
    		 Arm A: Lete-cel monotherapy No Treatment Arm C: Lete-cel + pembrolizumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 7 (71.43%)
    2 / 21 (9.52%)
    4 / 6 (66.67%)
         number of deaths (all causes)
    3
    5
    1
         number of deaths resulting from adverse events
    0
    0
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Cytokine release syndrome
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Aspiration
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Pleural effusion
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 21 (4.76%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 21 (4.76%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Blood bilirubin increased
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Pericardial effusion
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Immune effector cell-associated neurotoxicity syndrome
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 21 (4.76%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Pancytopenia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash maculo-papular
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Toxic skin eruption
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bacteraemia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Biliary tract infection
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Empyema
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Arm A: Lete-cel monotherapy No Treatment Arm C: Lete-cel + pembrolizumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 7 (100.00%)
    3 / 21 (14.29%)
    6 / 6 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Seborrhoeic keratosis
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Tumour pain
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    0
    Vascular disorders
    Haematoma
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Hypotension
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 21 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    2
    0
    1
    Orthostatic hypotension
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 21 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    2
    0
    2
    Face oedema
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Facial pain
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Fatigue
         subjects affected / exposed
    4 / 7 (57.14%)
    1 / 21 (4.76%)
    2 / 6 (33.33%)
         occurrences all number
    4
    1
    2
    Malaise
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Mucosal inflammation
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Oedema
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Oedema peripheral
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Pyrexia
         subjects affected / exposed
    5 / 7 (71.43%)
    0 / 21 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    5
    0
    1
    Chills
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Immune system disorders
    Cytokine release syndrome
         subjects affected / exposed
    4 / 7 (57.14%)
    0 / 21 (0.00%)
    4 / 6 (66.67%)
         occurrences all number
    4
    0
    5
    Haemophagocytic lymphohistiocytosis
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Hypersensitivity
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Aspiration
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Cough
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 21 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    3
    0
    1
    Dysphonia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Dyspnoea
         subjects affected / exposed
    3 / 7 (42.86%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    4
    0
    0
    Haemoptysis
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Hiccups
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Hypoxia
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    0
    Nasal congestion
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    2 / 6 (33.33%)
         occurrences all number
    0
    0
    2
    Pulmonary embolism
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    0
    Pulmonary oedema
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    1
    0
    1
    Rhinitis allergic
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Psychiatric disorders
    Hallucination
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    0
    Depression
         subjects affected / exposed
    3 / 7 (42.86%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    3
    0
    0
    Insomnia
         subjects affected / exposed
    2 / 7 (28.57%)
    1 / 21 (4.76%)
    1 / 6 (16.67%)
         occurrences all number
    2
    1
    1
    Persistent depressive disorder
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Investigations
    Neutrophil count decreased
         subjects affected / exposed
    3 / 7 (42.86%)
    0 / 21 (0.00%)
    4 / 6 (66.67%)
         occurrences all number
    4
    0
    4
    Activated partial thromboplastin time prolonged
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 21 (0.00%)
    2 / 6 (33.33%)
         occurrences all number
    2
    0
    3
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    2 / 6 (33.33%)
         occurrences all number
    1
    0
    3
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Blood creatinine increased
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    6
    0
    0
    Blood fibrinogen decreased
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Blood fibrinogen increased
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    0
    Blood methaemoglobin present
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    C-reactive protein increased
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    0
    Haemoglobin decreased
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    International normalised ratio increased
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    1
    0
    1
    Lymphocyte count decreased
         subjects affected / exposed
    7 / 7 (100.00%)
    1 / 21 (4.76%)
    4 / 6 (66.67%)
         occurrences all number
    8
    1
    4
    Platelet count decreased
         subjects affected / exposed
    4 / 7 (57.14%)
    0 / 21 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    5
    0
    1
    Serum ferritin increased
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Urine output decreased
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Weight decreased
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    3
    0
    0
    White blood cell count decreased
         subjects affected / exposed
    6 / 7 (85.71%)
    0 / 21 (0.00%)
    2 / 6 (33.33%)
         occurrences all number
    7
    0
    3
    Injury, poisoning and procedural complications
    Radiation necrosis
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Vascular access complication
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Fall
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    0
    Cardiac disorders
    Sinus tachycardia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    1
    0
    1
    Tachycardia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Atrial flutter
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    Dysarthria
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Cognitive disorder
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Dizziness
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Tremor
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Subarachnoid haemorrhage
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Somnolence
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Seizure
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Paraesthesia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 21 (4.76%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    1
    Intraventricular haemorrhage
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Immune effector cell-associated neurotoxicity syndrome
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    IIIrd nerve paralysis
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Headache
         subjects affected / exposed
    2 / 7 (28.57%)
    1 / 21 (4.76%)
    2 / 6 (33.33%)
         occurrences all number
    2
    1
    3
    Dysgeusia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    5 / 7 (71.43%)
    1 / 21 (4.76%)
    5 / 6 (83.33%)
         occurrences all number
    6
    1
    5
    Leukopenia
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    3
    0
    0
    Lymphopenia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    3
    0
    0
    Neutropenia
         subjects affected / exposed
    3 / 7 (42.86%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    3
    0
    0
    Pancytopenia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Thrombocytopenia
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 21 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    2
    0
    1
    Eye disorders
    Dry eye
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Lacrimation increased
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Abdominal pain
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Vomiting
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    3 / 6 (50.00%)
         occurrences all number
    0
    0
    3
    Abdominal pain upper
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Ascites
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Constipation
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    0
    Diarrhoea
         subjects affected / exposed
    3 / 7 (42.86%)
    0 / 21 (0.00%)
    3 / 6 (50.00%)
         occurrences all number
    3
    0
    3
    Dry mouth
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Dyspepsia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Dysphagia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Haematemesis
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Haematochezia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Lip dry
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Nausea
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 21 (0.00%)
    2 / 6 (33.33%)
         occurrences all number
    2
    0
    2
    Oral disorder
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Salivary hypersecretion
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Stomatitis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Abdominal pain lower
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Hypertransaminasaemia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Pruritus
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Night sweats
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Dry skin
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 21 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    2
    0
    1
    Dermatitis acneiform
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Alopecia
         subjects affected / exposed
    4 / 7 (57.14%)
    0 / 21 (0.00%)
    3 / 6 (50.00%)
         occurrences all number
    4
    0
    3
    Rash maculo-papular
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    3 / 6 (50.00%)
         occurrences all number
    1
    0
    3
    Rash morbilliform
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    0
    Rash erythematous
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Renal and urinary disorders
    Urinary incontinence
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    0
    Oliguria
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Haematuria
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Chronic kidney disease
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Acute kidney injury
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Urinary retention
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Endocrine disorders
    Hyperthyroidism
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Myalgia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Muscular weakness
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    2 / 6 (33.33%)
         occurrences all number
    0
    0
    2
    Muscle spasms
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Groin pain
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Flank pain
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Bone pain
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Back pain
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    3 / 6 (50.00%)
         occurrences all number
    1
    0
    4
    Arthralgia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    1
    0
    1
    Sacral pain
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Neck pain
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Infections and infestations
    Cytomegalovirus viraemia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Conjunctivitis
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Rash pustular
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Metabolism and nutrition disorders
    Cachexia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Decreased appetite
         subjects affected / exposed
    5 / 7 (71.43%)
    1 / 21 (4.76%)
    3 / 6 (50.00%)
         occurrences all number
    6
    1
    3
    Hyperchloraemia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Hyperglycaemia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    1
    0
    1
    Hyperkalaemia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Hyperphosphataemia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Hypertriglyceridaemia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Hypervolaemia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 21 (4.76%)
    1 / 6 (16.67%)
         occurrences all number
    2
    1
    1
    Hypocalcaemia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    4
    0
    1
    Hypokalaemia
         subjects affected / exposed
    2 / 7 (28.57%)
    1 / 21 (4.76%)
    1 / 6 (16.67%)
         occurrences all number
    4
    1
    1
    Hypomagnesaemia
         subjects affected / exposed
    2 / 7 (28.57%)
    1 / 21 (4.76%)
    0 / 6 (0.00%)
         occurrences all number
    6
    1
    0
    Hyponatraemia
         subjects affected / exposed
    4 / 7 (57.14%)
    0 / 21 (0.00%)
    2 / 6 (33.33%)
         occurrences all number
    12
    0
    2
    Malnutrition
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Hypophosphataemia
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 21 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Oct 2018
    Changes made to the protocol were requested by Regulatory Agency as a result of safety events which included 2 reports of Guillain-Barré syndrome in subjects who have received chemotherapy and GSK3377794 during clinical trials
    13 Feb 2019
    Study Arm C was added. Changes were made for clarity, at the request of sponsor partners and because they were requested by the Regulatory Agency.
    01 Oct 2019
    Removal of randomization to Arm A and Arm B, clarification of aspects related to participant enrollment and clarification regarding study stopping and pausing rules.
    29 Oct 2019
    Addition of fresh biopsy collection to perform antigen expression screening, in the absence of archival tumor tissue.
    21 Feb 2020
    Add clarification regarding measurable lesion, to remove docetaxel as exclusion criterion and add platinum-based combination chemotherapy as an inclusion criterion. Docetaxel therapy was removed as supportive therapy between leukapheresis and the start of lymphodepletion.
    17 May 2021
    Simplify/enhance screening and enrollment efforts Broaden participant eligibility Include additional safety tests and measures.
    04 Nov 2022
    Implementation of additional safety monitoring measures for Lete-cel Increase the upper end of the target dose range of transduced T cells from to 8×109 to 15×109 in order to maximize the delivery of cells for participants whose manufacture yields >8×109 transduced T cells.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The study was terminated for reasons pertaining to feasibility.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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