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.

Study Identifier:
ATX-ME-001
CT.gov Identifier:
NCT03997474
EudraCT Identifier:
2018-003446-16
EU Trial (CTIS) Number:
2024-513062-19-00
Study Contact Information:
(210) 593-5651 or [email protected]
Terminated/Withdrawn

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Study Summary

To evaluate safety and efficacy of clonal neoantigen T cells (cNeT) in patients with metastatic or recurrent melanoma.

To characterize the safety and clinical activity of ATL001, autologous clonal neoantigen reactive T cells (cNeTs) administered intravenously in adults with metastatic or recurrent melanoma.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Melanoma
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I/II
Sex
Female & Male
Age
18 - 75 Years
Study Drug
Drug: Experimental: Cohort A
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Drug: Intervention:
Drug: Experimental: Cohort B
Drug: Biological: ATL001
Drug: Experimental: Cohort C
Study Status
Indicates the current recruitment status or the expanded access status
Terminated/Withdrawn

Requirements information
Inclusion criteria
  • Patient must be at least 18 years old.
  • Patient must have given written informed consent.
  • Patients must have histologically confirmed diagnosis of melanoma.
  • Patient is considered medically fit to undergo procurement of starting material and ATL001 administration procedures.
  • ECOG Performance Status 0-1.
  • Adequate organ function per the laboratory parameters defined in the protocol.
  • Female patients who are of childbearing potential must agree to use a highly effective method of contraception during the study 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.
  • Anticipated life expectancy ≥ 6 months at the time of tissue procurement.
  • Measurable disease according to RECIST v1.1 criteria. Additional inclusion criteria will apply as per the study protocol.
Exclusion criteria
  • Patients with known leptomeningeal disease or untreated, symptomatic or progressing central nervous system (CNS) metastases. Lesions should be clinically and radiologically stable for 2 months after treatment and should not require steroids.
  • Patients with ocular, acral or mucosal melanoma.
  • Patients with hepatitis B or C, human immunodeficiency virus infection (HIV 1/2), syphilis or HTLV I/II infection.
  • Patients requiring immunosuppressive treatments.
  • Patients requiring regular steroids at a dose higher than prednisolone 10mg/day (or equivalent).
  • Patients with clinically significant, progressive, and/or uncontrolled renal, hepatic, haematological, endocrine, pulmonary, cardiac, gastroenterological, or neurological disease.
  • Patients with a history of immune mediated (CNS) toxicity or ≥ Grade 2 diarrhoea/colitis caused by, , previous immunotherapy within the past 6 months.
  • Patients who are pregnant or breastfeeding.
  • Patients who have undergone major surgery in the previous 3 weeks.
  • 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).
  • Patients with a history of organ transplantation.
  • Patients who have previously received any investigational cell or gene therapies.
  • Patients with contraindications for protocol specified agents.

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Madrid, Spain (CIOCC)
Madrid, Spain, 28050
Investigator
Maria de Miguel
Status
Terminated/Withdrawn
Condition(s) Treated at Site
Melanoma