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    Summary
    EudraCT Number:2018-003446-16
    Sponsor's Protocol Code Number:ATX-ME-001
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-06-02
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2018-003446-16
    A.3Full title of the trial
    An open-label, multi-centre, phase I/IIa study evaluating the safety and clinical activity of neoantigen reactive T cells in patients with metastatic or recurrent melanoma.
    Estudio en fase I/IIa sin ocultación y multicéntrico para evaluar la seguridad y la actividad clínica de los linfocitos T reactivos a los neoantígenos en pacientes con melanoma metastásico o recurrente
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A first-in-human clinical trial in adult patients with metastatic or recurrent melanoma of a personalised therapy targeting specific mutations that occur in all cancer cells within a single patient.
    Primer estudio en humanos en pacientes adultos con melanoma metastásico o recurrente, para la evaluación de una terapia personalizada que se dirige a mutaciones específicas que ocurren en todas las células de cáncer de un único paciente
    A.3.2Name or abbreviated title of the trial where available
    ATX-ME-001 - ATL001 for the Treatment of Metastatic or Recurrent Melanoma
    ATX-ME-001 - ATL001 para el tratamiento de Melanoma Metastásico o Recurrente
    A.4.1Sponsor's protocol code numberATX-ME-001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03997474
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAchilles Therapeutics UK Limited
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAchilles Therapeutics UK Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAchilles Therapeutics UK Limited
    B.5.2Functional name of contact pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street Address245 Hammersmith Road
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeW6 8PW
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+442045519198
    B.5.5Fax number+442081815141
    B.5.6E-mailregulatory@achillestx.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameATL001
    D.3.2Product code ATL001
    D.3.4Pharmaceutical form Dispersion for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot yet available
    D.3.9.3Other descriptive nameATL001
    D.3.9.4EV Substance CodeSUB193230
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number10000000 to 1000000000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product Yes
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Opdivo
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Pharma
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameOpdivo
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNivolumab
    D.3.9.3Other descriptive nameNivolumab
    D.3.9.4EV Substance CodeSUB122750
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number480
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Metastatic or recurrent melanoma
    Melanoma metastásico o recurrente
    E.1.1.1Medical condition in easily understood language
    Melanoma
    Melanoma
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10072454
    E.1.2Term Amelanotic melanoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10072452
    E.1.2Term Angiotropic melanoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10072447
    E.1.2Term Blue naevus-like melanoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10072453
    E.1.2Term Blue nevus-like melanoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10072449
    E.1.2Term Desmoplastic melanoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10025650
    E.1.2Term Malignant melanoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10025651
    E.1.2Term Malignant melanoma excision
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10063706
    E.1.2Term Malignant melanoma of eyelid
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10025653
    E.1.2Term Malignant melanoma of other specified sites of skin
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10025655
    E.1.2Term Malignant melanoma of skin
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10025656
    E.1.2Term Malignant melanoma of skin of ear and external auditory canal
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10025657
    E.1.2Term Malignant melanoma of skin of ear and external auricular canal
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10056767
    E.1.2Term Malignant melanoma of skin of eyelid, incl canthus
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10025658
    E.1.2Term Malignant melanoma of skin of eyelid, including canthus
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10025659
    E.1.2Term Malignant melanoma of skin of lip
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10056768
    E.1.2Term Malignant melanoma of skin of lower limb, incl hip
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10025660
    E.1.2Term Malignant melanoma of skin of lower limb, including hip
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10025661
    E.1.2Term Malignant melanoma of skin of other and unspecified parts of face
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10025662
    E.1.2Term Malignant melanoma of skin of scalp and neck
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10025663
    E.1.2Term Malignant melanoma of skin of trunk, except scrotum
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10056792
    E.1.2Term Malignant melanoma of skin of trunk, excl scrotum
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10056769
    E.1.2Term Malignant melanoma of skin of upper limb, incl shoulder
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10025664
    E.1.2Term Malignant melanoma of skin of upper limb, including shoulder
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10025670
    E.1.2Term Malignant melanoma stage III
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10025671
    E.1.2Term Malignant melanoma stage IV
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10053571
    E.1.2Term Melanoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10027149
    E.1.2Term Melanoma limited to extremity
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10027150
    E.1.2Term Melanoma malignant
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10048434
    E.1.2Term Melanoma malignant aggravated
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10027152
    E.1.2Term Melanoma of skin (malignant)
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10027153
    E.1.2Term Melanoma of skin, site unspecified
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10027154
    E.1.2Term Melanoma of trunk and head
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10066600
    E.1.2Term Melanoma recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10027155
    E.1.2Term Melanoma skin
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10027480
    E.1.2Term Metastatic malignant melanoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10027481
    E.1.2Term Metastatic melanoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10079054
    E.1.2Term Naevoid melanoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10079068
    E.1.2Term Nevoid melanoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10029488
    E.1.2Term Nodular melanoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10074800
    E.1.2Term Skin malignant melanoma excision
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10040891
    E.1.2Term Skin melanoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10027156
    E.1.2Term Skin melanomas (excl ocular)
    E.1.2System Organ Class 100000004858
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10042547
    E.1.2Term Superficial spreading melanoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10042551
    E.1.2Term Superficial spreading melanoma stage III
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10042552
    E.1.2Term Superficial spreading melanoma stage IV
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10047981
    E.1.2Term Wide excision of melanoma
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the safety and tolerability of the investigational product after administration to patients.
    Evaluar la seguridad y tolerabilidad del producto en investigación tras administración a los pacientes.
    E.2.2Secondary objectives of the trial
    To evaluate if patients have a clinically meaningful response to the investigational product.
    Evaluar si los pacientes tienen una respuesta con significado clínico al producto en investigación.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria will apply at multiple timepoints.

    Inclusion Criteria:
    1. Patient must be at least 18 years old at the screening visit.
    2. Patient must have given written informed consent to participate in the study.
    3. Patients must have histologically confirmed diagnosis of melanoma.
    4. Patients must have received a PD-1/PD-L1 inhibitor prior to treatment with ATL001 (unless contraindicated).
    5. Patients whose tumour is known to have a BRAF V600 mutation must have received BRAF targeted therapy (as well as a PD-1/PD-L1 inhibitor unless contraindicated) prior to treatment with ATL001.
    6. Patient is considered medically fit enough to undergo all study procedures and interventions: procedures to procure blood and tumour tissue, including a general anaesthetic if required, and to receive fludarabine, cyclophosphamide and IL-2 at protocol doses and schedules.
    7. Patient is considered, in the opinion of the Investigator, capable of adhering to the protocol.
    8. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
    9. Adequate organ function indicated by the following laboratory parameters:
    a. Haemoglobin ≥ 10.0 g/dL.
    b. White Blood Cell Count (WBC) ≥ 3.0 x10^9/L.
    c. Absolute Neutrophil Count (ANC) ≥ 1.5 x10^9/L.
    d. Platelets ≥ 100 x10^9/L.
    e. INR/PT and APTT < 1.5x ULN, unless receiving therapeutic anticoagulation. Investigator discretion is required to ensure surgery is safe or that anticoagulants can be safely stopped.
    f. AST or ALT ≤ 2.5x ULN.
    g. Bilirubin < 1.5x ULN (or < 3x ULN if Gilbert’s Syndrome).
    h. Creatinine clearance/estimated glomerular filtration rate (GFR) ≥ 50 mL/min.
    10. Female patients who are of childbearing potential must agree to use a highly effective method of contraception during the study and for at least 12 months after the ATL001 infusion. Non-sterilised male participants who intend to be sexually active with a female partner of childbearing potential must use an acceptable method of contraception from the time of screening, throughout the duration of the study and for at least 6 months after the ATL001 infusion. See Section 4.3 for details of acceptable methods of contraception.
    In addition to a re-evaluation of criteria 1-10, the following inclusion criteria must also be met prior to tissue procurement:
    11. To be eligible to enter this study for procurement, the patient must fall into one of the following groups (Note: Patients will not receive ATL001 until their disease has progressed or recurred following standard of care therapies, or if they cannot tolerate standard of care therapies – see inclusion number 13):
    a) Patients with metastatic or recurrent disease who have had no prior systemic therapy for advanced disease and who have accessible sites of disease suitable for collection of adequate tissue for ATL001 manufacture.
    b) Patients with metastatic or recurrent disease who are on or have completed first line systemic therapy and have accessible sites of disease suitable for collection of adequate tissue for ATL001 manufacture.
    c) Other patients with advance stage disease for whom no other alternative approved treatments are available, may be considered on a case-by-case basis and should be discussed with the Sponsor prior to enrolment.
    12. Anticipated life expectancy ≥ 6 months at the time of tissue procurement.
    In addition to a re-evaluation of criteria 1-10, the following inclusion criteria must also be met prior to lymphodepletion for treatment with ATL001:
    13. Patients must have metastatic melanoma whose disease has progressed or recurred following standard of care or who are ineligible for, or who cannot tolerate, standard of care therapies, e.g. immune checkpoint inhibitors.
    14. Patients must have measurable disease according to RECIST v1.1 criteria prior to lymphodepletion.
    15. Patient is considered, in the opinion of the Investigator, well enough (i.e. ECOG Performance Status 0-1) to receive ATL001 treatment (this will be checked prior to lymphodepletion and again prior to receiving ATL001).
    In addition to 1-15, the following inclusion criteria must be met for patients to be eligible for treatment in Cohort B:
    16. Prior to treatment with ATL001, the treatment regimen must have included a PD-1/PD-L1 inhibitor and patients should have experienced radiological disease progression on this treatment regimen.
    17. In addition to the need for highly effective contraception as outlined in Inclusion Criterion 10 above, female patients in Cohort B of childbearing potential must agree to use effective contraception during treatment with nivolumab and for at least 5 months after the last dose of nivolumab. Patients must also agree to provide a serum or urine pregnancy test before each nivolumab administration during the treatment period in Cohort B.
    Los criterios de inclusión se aplicarán en varios momentos del ensayo.
    1.Los pacientes deberán tener al menos 18 años en la visita de selección
    2.El paciente debe haber dado su consentimiento informado escrito para participar en el estudio
    3.Los pacientes deben tener un diagnóstico histológico confirmado de melanoma
    4.Los pacientes deben haber recibido inhibidores PD-1/PD-L1 antes del tratamiento con ATL001 (a no ser que esté contraindicado)
    5.Los pacientes cuyo tumor se sabe que tiene una mutación BRAF V600 deben haber recibido terapia dirigida a BRAF (así como PD-1/PD-L1 inhibidores a no ser que esté contraindicado) antes del tratamiento con ATL001
    6.El paciente es considerado médicamente apto para llevar a cabo todos los procedimientos e intervenciones del estudio: procedimientos para obtener sangre y tejido tumoral, incluyendo anestesia general, si se requiere, y recibir fludarabina, ciclofosfamida e IL-2 a las dosis y horarios especificados en el protocolo
    7.El paciente es considerado, en opinión del investigador, capaz de adherirse al protocolo
    8.Estatus de 0-1 de calidad de vida en la escala Eastern Cooperative Oncology Group (ECOG)
    9.Funcionamiento adecuado de los órganos indicado por los siguientes parámetros de laboratorio:
    a.Hemoglobina≥10.0 g/dL
    b.Recuento de glóbulos blancos en sangre(WBC)≥3.0x10^9/L
    c.Recuento absoluto de neutrófilos(ANC)≥1.5 x10^9/L
    d.Plaquetas≥100 x10^9/L
    e.INR/PT o ALT ≤2.5xULN
    f.Bilirrubina<1.5x ULN (o <3xULN en pacientes con Síndrome de Gilbert)
    g.Depuración de creatinina/estimación de la tasa de filtración glomerular(GFR)≥50mL/min
    10.Las pacientes en edad fértil deben acceder a usar un método anticonceptivo altamente efectivo durante el estudio y al menos 12 meses después de la infusión de ATL001. Los pacientes hombres no esterilizados que tengan la intención de ser sexualmente activos con una pareja femenina en edad fértil deben usar anticonceptivos adecuados desde la visita de selección, durante la duración del estudio y por al menos 6 meses tras la infusión de ATL001. Ver la sección 4.3 para detalles sobre métodos anticonceptivos adecuados.
    Además de la reevaluación de los criterios 1-10, los siguientes criterios de inclusión deben cumplirse antes de la obtención de tejido:
    11.Para ser elegible para este estudio de obtención, el paciente debe pertenecer a uno de los siguientes grupos (Nota:los pacientes no recibirán ATL001 hasta que su enfermedad haya progresado o recurrido tras tratamiento de cuidado estándar, o si no pueden tolerar el tratamiento de cuidado estándar – ver núm. 13 de inclusión):
    a.Pacientes con enfermedad recurrente o metastásica que no han recibido terapia sistémica previa para enfermedad avanzada y que tienen sitios accesibles de enfermedad para la obtención de tejido adecuado para la producción de ATL001
    b.Pacientes con enfermedad metastásica o recurrente que estén o hayan completado la terapia sistémica de primera línea y que tengan sitios accesibles para la obtención de tejido adecuado para la producción de ATL001
    c.Otros pacientes con enfermedad de estado avanzado para los cuales no hay disponibles tratamientos alternativos aprobados, pueden ser considerandos caso por caso y tras discusión con el promotor
    12.Esperanza de vida anticipada ≥6 meses en el momento de la obtención de tejido
    Además de la reevaluación de criterios 1-10, los siguientes criterios de inclusión deben cumplirse antes de la depleción linfocítica para el tratamiento con ATL001:
    13.Los pacientes deben tener melanoma metastásico cuya enfermedad haya progresado o recurrido siguiendo tratamientos estándar o que no sean elegibles, o no puedan tolerar, los tratamientos de cuidado estándar, por ej. los inhibidores de checkpoints inmunes
    14.Los pacientes deben tener una enfermedad medible de acuerdo con los criterios de RECIST v1.1 antes de la depleción linfocítica
    15.El paciente está considerado, en opinión del investigador, suficientemente bien (estatus de desempeño ECOG 0-1) para recibir el tratamiento ATL001 (deberá ser evaluado antes de la depleción linfocítica y otra vez antes de recibir ATL001).
    Además de los criterios 1-15, los siguientes criterios de inclusión deben cumplirse para que los pacientes sean elegibles para el tratamiento en la Cohorte B:
    16.Antes del tratamiento con ATL001, el régimen de tratamiento debe haber incluido inhibidores PD-1/PD-L1 y los pacientes deben haber experimentado progresión en la enfermedad según pruebas radiológicas, con este régimen de tratamiento
    17.Además de la necesidad para métodos anticonceptivos altamente efectivos, las pacientes de la Cohorte B que estén en edad fértil deben acceder a utilizar métodos anticonceptivos efectivos durante el tratamiento con nivolumab y al menos 5 meses después de la última dosis de nivolumab. Las pacientes deben acceder también a realizar tests de embarazo de suero u orina antes de cada administración de nivolumab durante el periodo de tratamiento en la Cohorte B.
    E.4Principal exclusion criteria
    Exclusion criteria will apply at multiple timepoints.

    Exclusion Criteria:
    1. Patients with known leptomeningeal disease or central nervous system (CNS) metastases that are untreated or symptomatic or progressing.
    2. Patients with ocular, acral or mucosal melanoma.
    3. Patients with hepatitis B or C, human immunodeficiency virus infection (HIV1/2), syphilis or HTLVI/II infection (see Section 6.1.1).
    4. Patients with active, known, or suspected autoimmune disease requiring immunosuppressive treatments.
    5. Patients requiring regular treatment with steroids at a dose higher than prednisolone 10 mg/day (or equivalent).
    6. Patients with a current or recent history, as determined by the Investigator, of clinically significant, progressive, and/or uncontrolled renal, hepatic, haematological, endocrine, pulmonary, cardiac, gastroenterological or neurological disease.
    7. Patients with a history of immune mediated central nervous system toxicity that was caused by, or suspected to be caused by, immunotherapy.
    8. Patients with a history of ≥ Grade 2 diarrhoea/colitis caused by previous immunotherapy within 6 months of screening. Patients that have been asymptomatic for at least 6 months or have had a normal colonoscopy postimmunotherapy (with uninflamed mucosa by visual assessment following discontinuation of immune suppression other than permitted modified release steroids) are not excluded.
    9. Patients who are pregnant or breastfeeding.
    10. Patients who have undergone major surgery in the previous 3 weeks.
    11. Patients with an active concurrent cancer or a history of cancer within the past 3 years (except for in situ carcinomas, early prostate cancer with normal Prostate-Specific Antigen (PSA) or non-melanomatous skin cancers).
    12. Patients with a history of organ transplantation.
    13. Patients who have previously received any investigational cell or gene therapies.
    14. Patients with contraindications for cyclophosphamide, fludarabine and IL-2 at per protocol doses (see Investigator’s Brochure for details).
    15. Patients with a confirmed history of allergic reactions to amphotericin b, penicillin and/or streptomycin.
    In addition to 1-15, the following exclusion criteria apply to patients who have received anti-cancer therapy prior to study entry:
    16. Patients who have received any cytotoxic chemotherapy within the 3 weeks prior to tissue and blood procurement.
    In addition, the following exclusion criteria will apply for eligibility for Cohort B:
    17. Patients with a history of (non-infectious) pneumonitis that required systemic steroids, or current pneumonitis/interstitial lung disease.
    18. Patients with a history of severe hypersensitivity to a monoclonal antibody, allergy or hypersensitivity to nivolumab itself and/or its components.
    19. Patients who have received a live vaccination within the 28 days prior to the first dose of nivolumab.
    20. Patients with any contraindications for nivolumab (Refer to the latest available prescribing information (e.g. SmPC) for reference safety information for nivolumab).
    In addition, the following exclusion criteria will apply for eligibility for Cohort C:
    21. Patients with a Left Ventricular Ejection Fraction (LVEF) < 45%. Patients > 60 years of age must have had an echocardiogram within the previous 60 days of screening.
    22. Patients with a forced expiratory volume in one second (FEV1) of less than o equal to 60% of their predicted normal.
    All exclusion criteria, except 3 and 16, will apply again prior to lymphodepletion for treatment with ATL001.
    In addition, the following criteria will apply:
    23. Patients who have received a live vaccination within the 28 days prior to lymphodepletion.
    24. Patients with an active infection requiring antibiotics.
    25. Patients who have received any cytotoxic chemotherapy within the 3 weeks prior to lymphodepletion.
    Los criterios de inclusión se aplicarán en varios momentos del ensayo.
    Criterios de exclusión:
    1. Pacientes con leptomeningitis o metástasis en el sistema nervioso central que no son tratadas o son sintomáticas o en progreso
    2. Pacientes con melanoma ocular, acral o de mucosa
    3. Pacientes con infección por hepatitis B o C, el virus de inmunodeficiencia humana (VIH1/2), sífilis o HTLVI/II (ver sección 6.1.1)
    4. Pacientes con enfermedad autoinmune activa, conocida, o sospechada, que requieren tratamientos inmunosupresores.
    5. Pacientes que requieren tratamiento regular con esteroides a una dosis más alta que 10mg/día de prednisolona (o equivalente)
    6. Pacientes con historia reciente o actual, determinado por el investigador, de enfermedad renal, hepática, hematológica, endocrina, pulmonar, cardiaca, gastroenterológica o neurológica, clínicamente significante, progresiva y/o incontrolada
    7. Pacientes con antecedentes de inmuno-toxicidad en el sistema nervioso central que fue causado por, o sospechado de ser causado por, inmunoterapia.
    8. Pacientes con antecedentes de diarrea/colitis ≥ grado 2 causada por inmunoterapia en los 6 meses previos al cribado. Pacientes que han sido asintomáticos por al menos 6 meses o que han tenido una colonoscopia normal post-inmunoterapia (con mucosa no inflamada según evaluación visual tras la descontinuación de la supresión inmune, excepto los esteroides permitidos de liberación modificada) son excluidos.
    9. Pacientes que están embarazadas o lactando
    10. Pacientes que han sido sometidos a una cirugía mayor en las 3 semanas previas
    11. Pacientes con cáncer concurrente activo o antecedentes de cáncer en los últimos 3 años (excepto carcinomas in situ, cáncer temprano de próstata con valores normales de PSA o cáncer de piel no melanomatoso).
    12. Pacientes con antecedentes de trasplante de órganos
    13. Pacientes que han recibido previamente alguna terapia celular o génica en investigación
    14. Pacientes con contraindicaciones para ciclofosfamida, dludarabina e IL-2 a las dosis de protocolo (ver los detalles del manual del investigador)
    15. Pacientes con antecedentes confirmados de reacciones alérgicas a anfotericina b, penicilina y/o estreptomicina
    Además de los puntos 1-15, los siguientes criterios de exclusión aplican a pacientes que han recibido terapia anti-cáncer antes de ingresar en el estudio:
    16. Pacientes que han recibido alguna quimioterapia citotóxica durante las 3 semanas anteriores a la recogida de tejido y sangre.
    Además, los siguientes criterios de exclusión aplicarán para la elegibilidad de la Cohorte B:
    17. Pacientes con antecedentes de neumonitis (no infecciosa) que requirieron esteroides sistémicos, o con actual neumonitis/enfermedad de pulmón intersticial.
    18. Pacientes con antecedentes de hipersensibilidad severa a anticuerpos monoclonales, alergia o hipersensibilidad a nivolumab y/o a alguno de sus componentes.
    19. Pacientes que han recibido una vacuna viva en los 28 días previos a la primera dosis de nivolumab
    20. Pacientes con alguna contraindicación a nivolumab (refiérase a la información de prescripción más reciente (por ej. SmPC) para información de referencia de seguridad de nivolumab
    Además, los siguientes criterios de exclusión aplicarán para elegibilidad para la Cohorte C:
    21. Pacientes con fracción de eyección del ventrículo izquierdo (LVEF) <45%. Pacientes >60 años deben haber realizado un ecocardiograma dentro de los 60 días previos al cribado
    22. Pacientes con volumen espiratorio forzado en el primer segundo (FEV1) de menos o igual a 60% de su valor normal predicho.
    Todos los criterios de exclusión, excepto el 3 y el 16, aplicarán de nuevo antes de la depleción linfocítica para el tratamiento con ATL001.
    Además, los siguientes criterios aplicarán:
    23. Pacientes que hayan recibido una vacuna viva dentro de los 28 días previos a la depleción linfocítica
    24. Pacientes con una infección activa que requiera antibióticos
    25. Pacientes que hayan recibido alguna quimioterapia citotóxica dentro de las 3 semanas anteriores a la depleción linfocítica
    E.5 End points
    E.5.1Primary end point(s)
    To assess the safety and tolerability of ATL001 as a monotherapy and in combination with nivolumab:

    Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) following tissue procurement and administration of lymphodepletion agents, ATL001 (monotherapy or in combination with nivolumab) and IL-2.
    Evaluar la seguridad y tolerabilildad de ATL001 como monoterapia y en combinación con nivolumab.

    Frecuencia y severidad de los efectos adversos (AEs) y efectos adversos serios (SAEs) tras la obtención de tejido y administración de los agentes de depleción linfocítica, ATL001 (monoterapia o en combinación con nivolumab) e IL-2.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The following interim analyses of efficacy may be performed:

    1. Optional interim analyses when approximately 10 evaluable patients have been followed up for 6 and 12 weeks.
    2. An interim analysis of each treatment cohort separately when all patients in a cohort have been followed up for 12 weeks.
    3. A final analysis when all patients have either died or have been followed up for 2 years.

    Additional interim analyses may be performed at other times during the study.
    Los siguientes análisis intermedios de eficacia serán realizados:
    1. Análisis opcionales intermedios cuando aproximadamente 10 pacientes evaluables se hayan seguido por 6 y 12 semanas
    2. Una evaluación intermedia para cada cohorte de tratamiento por separado cuando todos los pacientes dentro de una cohorte hayan sido seguidos por 12 semanas
    3. Un análisis final cuando todos los pacientes hayan muerto o hayan sido seguidos durante 2 años
    Se pueden realizar evaluaciones intermedias adicionales en otros tiempos durante el estudio.
    E.5.2Secondary end point(s)
    To evaluate the clinical activity of ATL001 treatment as a monotherapy and in combination with nivolumab:

    • Percentage change from baseline in tumour size at 6 weeks, 12 weeks and best change from baseline.
    • Overall Response Rate (based on RECIST v1.1 and imRECIST).
    • Time to response (based on RECIST v1.1 and imRECIST).
    • Duration of response (based on RECIST v1.1 and imRECIST).
    • Disease Control Rate (CR + PR + durable SD) (based on RECIST v1.1).
    • Progression free survival (based on RECIST v1.1 and imRECIST).
    • Overall survival.
    Evaluar la actividad clínica del tratamiento de ATL001 como monoterapia y en combinación con nivolumab:
    • Cambio de porcentaje desde nivel basal en el tamaño de tumor a las 6 semanas, 12 semanas y cuando sea el mejor cambio desde nivel basal
    • Tasa de respuesta global (basada en RECIST v1.1 e imRECIST)
    • Tiempo de respuesta (basado en RECIST v1.1 e imRECIST)
    • Duración de la respuesta (basada en RECIST v1.1 e imRECIST)
    • Tasa de control de la enfermedad (CR + PR + SD duradera) (basado en RECIST v1.1)
    • Supervivencia global
    E.5.2.1Timepoint(s) of evaluation of this end point
    The following interim analyses of efficacy may be performed:

    1. Optional interim analyses when approximately 10 evaluable patients have been followed up for 6 and 12 weeks.
    2. An interim analysis of each treatment cohort separately when all patients in a cohort have been followed up for 12 weeks.
    3. A final analysis when all patients have either died or have been followed up for 2 years.

    Additional interim analyses may be performed at other times during the study.
    Deberían realizarse los siguientes análisis intermedios de eficacia:
    1. Análisis opcional intermedio cuando aproximadamente 10 pacientes evaluables han sido seguidos durante 6 y 12 semanas
    2. Una evaluación intermedia para cada cohorte de tratamiento por separado cuando todos los pacientes dentro de una cohorte hayan sido seguidos por 12 semanas
    3. Un análisis final cuando todos los pacientes hayan muerto o hayan sido seguidos durante 2 años
    Se pueden realizar evaluaciones intermedias adicionales en otros tiempos durante el estudio.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    Spain
    Germany
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days29
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days29
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 11
    F.4.2.2In the whole clinical trial 40
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The investigational medicinal product is administered as a single infusion of autologous cells. It is anticipated that most patients will receive a single administration of cells. Re-administration may be possible if the patient is fit enough to undergo a second tumour biopsy for the manufacture of a second dose or re-conditioning with fludarabine and cyclophosphamide if needed in the case a second dose was able to be manufactured from the initial tumour biopsy upon initial entry to the study.
    El producto medicinal en investigación es administrado como una infusión única de células autólogas. La re-administración puede ser posible si el paciente está suficientemente en forma para someterse a una segunda biopsia de tumor para la fabricación de una segunda dosis, o para el re-acondicionamiento con fludarabina y ciclofosfamida si se necesita en el caso de que no se pueda fabricar una segunda dosis a partir de la biopsia de tumor inicial realizada en la entrada al estudio.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-07-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-20
    P. End of Trial
    P.End of Trial StatusOngoing
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