Clinical Trial Results:
An open-label phase II single-centre study investigating the safety and efficacy of LTX-315 and adoptive T-cell therapy in patients with advanced/metastatic soft tissue sarcoma
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Summary
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EudraCT number |
2017-002877-20 |
Trial protocol |
DK |
Global end of trial date |
11 Oct 2021
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Results information
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Results version number |
v1(current) |
This version publication date |
05 Jan 2023
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First version publication date |
05 Jan 2023
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Other versions |
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Summary report(s) |
Exploratory endpoints results |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
C17-315-04
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03725605 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Lytix Biopharma AS
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Sponsor organisation address |
Sandakerveien 138, Oslo, Norway, 0484
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Public contact |
Oystein Rekdal, Lytix Biopharma AS, +47 975 73 358, Oystein.Rekdal@lytixbiopharma.com
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Scientific contact |
Baldur Sveinbjornsson, Lytix Biopharma AS, +47 413 44 682, Baldur.Sveinbjornsson@lytixbiopharma.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
15 Sep 2022
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
02 Jul 2021
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Global end of trial reached? |
Yes
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Global end of trial date |
11 Oct 2021
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
* To determine the ability of LTX-315 to induce T-cell infiltration prior to TIL expansion in advanced/metastatic soft tissue sarcoma
* To determine the safety of LTX-315 as part of adoptive T-cell therapy in
advanced/metastatic soft tissue sarcoma
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Protection of trial subjects |
The study was performed in accordance with the CSP version 2.0 and 3.0, and the current revision of the Declaration of Helsinki, as well as with the Note for Guidance on Good Clinical Practice and applicable regulatory requirements.
Prophylactic treatment (antihistamines and a leukotriene antagonist) was initiated in all patients prior to administration of LTX-315.
For T-cell therapy, prophylactic treatment included i.v. administration of cyclophosphamide as well as supportive treatment.
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Background therapy |
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Evidence for comparator |
- | ||
Actual start date of recruitment |
01 May 2018
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Denmark: 6
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Worldwide total number of subjects |
6
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EEA total number of subjects |
6
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
5
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From 65 to 84 years |
1
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85 years and over |
0
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Recruitment
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Recruitment details |
All subjects were treated at the CCIT, Herlev Hospital, Denmark. The majority of the subjects were recruited in Denmark, while 1 subject was identified in Norway and referred to Denmark for screening procedures and treatment. | ||||||||||
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Pre-assignment
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Screening details |
A total of 7 subjects were screened and 6 subjects were enrolled in the study. | ||||||||||
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Period 1
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Period 1 title |
LTX-315 treatment (Step 1)
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Is this the baseline period? |
Yes | ||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||
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Arms
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Arm title
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LTX-315 treatment (Step 1) | ||||||||||
Arm description |
This is a one-arm study where all subjects received LTX-315 during Step 1. | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
LTX-315
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Investigational medicinal product code |
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Other name |
Ruxotemitide
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Intratumoral use
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Dosage and administration details |
• LTX-315 was administered on dosing days (i.e., Step 1, Days 1, 2, 3 and 8 were mandatory, Days 15 and 22 were optional)
• The index tumour lesion for injection needed to have a minimum LD of 1 cm as measured by ultrasound or calliper
• The LTX-315 dose was 5 mg (10 mg/ml concentration) at each injection time point
• The number of LTX-315 injections to a single lesion on an LTX-315 dosing day could vary depending on the volume of that lesion:
- Lesions (< 3cm LD) could receive up to 4 injections per day (i.e., a total daily dose of up to 20 mg)
- Lesions (> 3cm LD) could receive up to 12 injections per day (i.e., a total maximum daily dose of 60 mg)
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Period 2
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Period 2 title |
Adoptive T-cell therapy (Step 2)
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Is this the baseline period? |
No | ||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||
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Arms
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Arm title
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Adoptive T-cell therapy (Step 2) | ||||||||||
Arm description |
This is a one-arm study where subjects underwent TIL infusion and received chemotherapy and interleukin treatment during Step 2. | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
Tumour Infiltrating Lymphocytes (TILs)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Infusion
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Dosage and administration details |
Subjects with successful TIL expansion received TIL infusion. The infusion was performed on one single day. The number of T-cells in the product depended on the achieved level of in vitro expansion and the number of TILs infused varied between subjects, ranging from 44x10^9 TILs to 63x10^9 TILs.
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Investigational medicinal product name |
Cyclophosphamide
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder for solution for injection/infusion
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Routes of administration |
Infusion
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Dosage and administration details |
Cyclophosphamide was given as an intravenous infusion for 2 consecutive days in a dose of 60 mg per kg of body weight.
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Investigational medicinal product name |
Fludarabine phosphate
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate for solution for injection/infusion
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Routes of administration |
Infusion
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Dosage and administration details |
Fludarabine phosphate was given as an intravenous infusion for 5 consecutive days in a dose of 25 mg per m2 body surface (starting the day after the last dose of cyclophosphamide).
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Investigational medicinal product name |
Interleukin 2
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder for solution for injection/infusion
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Routes of administration |
Injection
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Dosage and administration details |
Daily subcutaneous injections with IL-2 (2 MIU) were administered from Day 1 to 14.
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Baseline characteristics reporting groups
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Reporting group title |
LTX-315 treatment (Step 1)
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Reporting group description |
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End points reporting groups
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Reporting group title |
LTX-315 treatment (Step 1)
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Reporting group description |
This is a one-arm study where all subjects received LTX-315 during Step 1. | ||
Reporting group title |
Adoptive T-cell therapy (Step 2)
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Reporting group description |
This is a one-arm study where subjects underwent TIL infusion and received chemotherapy and interleukin treatment during Step 2. | ||
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End point title |
Change in total T-cell level in tumour tissues from Baseline (Step 1, Week 1, Day 1) to end of Step 1 (Step 1, Week 3) [1] | ||||||||
End point description |
The primary efficacy endpoint was change in total T-cell level in tumour tissues from baseline (Step 1, Week 1, Day 1) to end of Step 1. In Step 1 the total T-cell level was measured at baseline and end of Step 1. Absolute values and change from baseline (Step 1, Week 1, Day 1) for T-cell level were listed for the FAS. Change from baseline was listed as absolute change. Data are presented as the arithmetic mean value for the factor increase (+) or decrease (-) in number of cells/mm2 from baseline to end of Step 1.
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End point type |
Primary
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End point timeframe |
15 to 42 days (Step 1, W1, D1 to end of Step 1)
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| 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: No formal hypothesis testing was planned for this study due to the low number of subjects included. A total of 6 patients were enrolled of whom 3 were included using the CSP v2.0 and 3 patients were included using the CSP v3.0. The 2 versions differ in amount and timepoints of visits and IMP administrations. CSP v3.0 also allowed the inclusion of subjects that were in stable disease at baseline, and therefore, data from patients enrolled using different protocols cannot be compared. |
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| Notes [2] - For 1 subject evaluation was not possible due to complete necrosis of the injected lesion |
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| No statistical analyses for this end point | |||||||||
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End point title |
Adverse events (AE) related to LTX-315 or to the combination of LTX-315 and adoptive T-cell therapy from Baseline (Step 1, Week 1, Day 1) to end of treatment (EoT) (Step 2, Week 7) [3] | |||||||||||||||
End point description |
The primary safety endpoint was AEs related to LTX-315 or to the combination of LTX-315 and adoptive T-cell therapy from baseline (Step 1, Week 1, Day 1) to end of treatment (Step 2, Week 7).
AEs were events occurring during or after administration of the IMP. AEs were coded using MedDRA version 21.1 and were classified by System Organ Class (SOC), Preferred Term (PT) and Lowest Level Term (LLT).
Adverse events related to LTX-315 were events where causality to LTX-315 was marked on the adverse events page.
Adverse events related to the combination of LTX-315 and adoptive T-cell therapy were events where both causality to LTX-315 and at least one of the other IMPs (TILs, Sendoxan®, Fludara® and Proleukin®) were marked on the adverse event page.
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End point type |
Primary
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End point timeframe |
Up to 133 days (from Step 1, Week 1, Day 1 to Step 2, Week 7)
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| 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: No formal hypothesis testing was planned for this study due to the low number of subjects included. A total of 6 patients were enrolled of whom 3 were included using the CSP v2.0 and 3 patients were included using the CSP v3.0. The 2 versions differ in amount and timepoints of visits and IMP administrations. CSP v3.0 also allowed the inclusion of subjects that were in stable disease at baseline, and therefore, data from patients enrolled using different protocols cannot be compared. |
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| No statistical analyses for this end point | ||||||||||||||||
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End point title |
Change in CD3+ T-cell and CD3+CD8+ T cell density in non-injected tumour tissues from Baseline (Step 1, Week 1, Day 1) to EoT (Step 2, Week 7) | ||||||||
End point description |
The change in CD3+CD8+ T-cells from baseline to end of Step 2 could only be evaluated for 1 subject. The change is described as factor increase.
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End point type |
Secondary
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End point timeframe |
133 days (from Step 1, Week 1, Day 1 to end of Step 2, Week 7).
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| Notes [4] - Data was only available for 1 subject |
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| No statistical analyses for this end point | |||||||||
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End point title |
Total number of CD3+CD8+ T-cells in TIL infusion product | ||||||||
End point description |
TIL expansion took place between Step 1 and Step 2 for a period of 41-49 days. The composition of the TIL infusion product was evaluated for the 4 subjects for whom it was possible to grow TILs. For 2 subjects it was not possible to meet the criteria of 4x10^7 cells as described in the IMPD.
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End point type |
Secondary
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End point timeframe |
TIL expansion took place between Step 1 and Step 2, i.e., during a period of 41-49 days.
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| Notes [5] - The TIL infusion product was evaluated for the 4 subjects for whom it was possible to grow TILs. |
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| No statistical analyses for this end point | |||||||||
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End point title |
% CD3+CD8+ T-cells of total CD3+ in TIL infusion product | ||||||||
End point description |
TIL expansion took place between Step 1 and Step 2 for a period of 41-49 days. The composition of the TIL infusion product was evaluated for the 4 subjects for whom it was possible to grow TILs. For 2 subjects it was not possible to meet the criteria of 4x10^7 cells as described in the IMPD.
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End point type |
Secondary
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End point timeframe |
TIL expansion took place between Step 1 and Step 2, i.e., during a period of 41-49 days.
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| Notes [6] - The TIL infusion product was evaluated for the 4 subjects for whom it was possible to grow TILs. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Objective response rate | ||||||||||||
End point description |
The ORR was defined as the proportion of subjects who according to RECIST 1.1 achieved complete response or partial response at EoT (Step 2, Week 7) and up to 15 months after EoT.
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End point type |
Secondary
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End point timeframe |
Endpoint evaluated at EoT (Step 2, Week 7) and up to 15 months after EoT.
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| Notes [7] - ORR was evaluated for the 4 subjects who progressed to Step 2. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Clinical benefit rate | ||||||||||||
End point description |
The CBR was defined as proportion of subjects who according to RECIST 1.1 had achieved complete response, partial response or stable disease at EoT (Step 2, Week 7) and up to 15 months after EoT. CBR was evaluated at Step 2, Week 7 and Week 13.
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End point type |
Secondary
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End point timeframe |
Endpoint evaluated at at EoT (Step 2, Week 7) and up to Week 13.
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| Notes [8] - The endpoint was evaluated for the 4 subjects who progressed to Step 2. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Best overall tumour response | ||||||||||
End point description |
BOR was defined in the CSP as the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started).
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End point type |
Secondary
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End point timeframe |
Assessed at Visit 25 (Step 2, Week 7, Day 42).
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| Notes [9] - Evaluated for the 4 subjects who progressed to Step 2. |
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| No statistical analyses for this end point | |||||||||||
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End point title |
Progression free survival | ||||||||
End point description |
PFS was calculated as number of days from date of screening (Baseline) until date of progressive disease or up to 15 months after EoT.
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End point type |
Secondary
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End point timeframe |
From screening (Baseline) until date of progressive disease or up to 15 months after EoT.
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| Notes [10] - Endpoint evaluated for the 4 subjects who progressed to Step 2. |
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| No statistical analyses for this end point | |||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Up to 133 days
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Adverse event reporting additional description |
AEs were events occurring during or after administration of IMP. AEs were coded using the MedDRA version 21.1 and were classified by SOC, PT and LLT.
AEs were collected from the time the patient signed the informed consent form to end of study (Step 2, Week 7, Day 42)
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
21.1
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Reporting groups
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Reporting group title |
All subjects
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Reporting group description |
AEs are presented overall, i.e., from Step 1, Week 1, Day 1 to end of Step 2, Week 7, Day 42 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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05 Sep 2018 |
A non-substantial amendment (Amendment#01) was issued 05 September 2018 and included:
• Adding how to handle pregnancies
• Clarifications of adverse event reporting procedures
• Elaboration of definitions (Clinical Significant laboratory adverse events, not related causality, severity, Common Terminology Criteria for Adverse Events)
• Change of pharmacovigilance Contract Research Organisation
• Change of serious adverse event reporting to be via electronic case report form and paper as back-up
• Updates of project managers and medical personnel (KLIFO A/S and Lytix Biopharma A/S)
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31 Mar 2021 |
A substantial amendment (Amendment#02) was issued 31 March 2021 and included:
• Change/update of inclusion criteria 1, 2, 3 and 11
• Follow-up period shortened from 2 years to 15 months
• IrRC obsolete, only RECIST will be measured.
• Secondary endpoints updated to conform with secondary objectives
• Stable disease (SD) included that change the table 6.1
• Reference 51 updated with RECIST publication
• Treatment time (days) when IMP is given, changed
• Safety update
• Personnel changes (including tasks) at Lytix A/S and KLIFO A/S
• Appendix IV updated with RECIST
• Added table with Key changes to the protocol
• Updated abbreviation list
• Study design graph updated
• Table 5 updated
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| TIL infusion during Step 2 of the study depended on TIL expansion being successful. Successful TIL expansion was achieved for 4/6 subjects hence secondary efficacy endpoints were evaluable for only 4 subjects. | |||
