ATL001 in Patients With Metastatic or Recurrent Melanoma

NCT ID: NCT03997474

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-15
• Study Completion Date: 2024-09-03

Brief Summary

This is a first-in-human, open-label, multi-centre, phase I/IIa study to characterize the safety and clinical activity of ATL001, autologous clonal neoantigen reactive T cells (cNeT) administered intravenously in adults with metastatic or recurrent melanoma.

Detailed Description

This is a first-in-human, open-label, multi-centre, phase I/IIa study to characterize the safety and clinical activity autologous clonal neoantigen reactive T cells (cNeT) administered intravenously in adults with metastatic or recurrent melanoma.

Patients will initially enter the study for procurement of tumour materials required to manufacture ATL001.Following manufacture of ATL001, the product will be given back to eligible patients following lymphodepletion.

Patients will be followed up for a period of 24 months post ATL001 infusion in the study.

Patients will continue to be followed up for a minimum of 5 years, as part of a separate Long Term Follow Up Protocol, or, if the separate protocol is not available at the study site, within this protocol.

Conditions

Melanoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort A

Following lymphodepletion, infusion of cell therapy product ATL001, followed by a low dose regimen of IL- 2.

Group Type: EXPERIMENTAL

ATL001

Intervention Type: BIOLOGICAL

ATL001 infusion

Cohort B

Following lymphodepletion, infusion of cell therapy product ATL001 in combination with a checkpoint inhibitor, followed by a low dose regimen of IL-2.

Group Type: EXPERIMENTAL

ATL001

Intervention Type: BIOLOGICAL

ATL001 infusion

Checkpoint Inhibitor

Intervention Type: DRUG

Nivolumab

Cohort C

Following lymphodepletion, infusion of cell therapy product ATL001, followed by a higher dose regimen of IL-2.

Group Type: EXPERIMENTAL

ATL001

Intervention Type: BIOLOGICAL

ATL001 infusion

Interventions

ATL001

ATL001 infusion

Intervention Type: BIOLOGICAL

Checkpoint Inhibitor

Nivolumab

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patient must be at least 18 years old.

2. Patient must have given written informed consent.

3. Patients must have histologically confirmed diagnosis of melanoma.

4. Patient is considered medically fit to undergo procurement of starting material and ATL001 administration procedures.

5. ECOG Performance Status 0-1.

6. Adequate organ function per the laboratory parameters defined in the protocol.

7. 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.

8. Anticipated life expectancy ≥ 6 months at the time of tissue procurement.

Exclusion Criteria

1. 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.

2. Patients with ocular, acral or mucosal melanoma.

3. Patients with hepatitis B or C, human immunodeficiency virus infection (HIV 1/2), syphilis or HTLV I/II infection.

4. Patients requiring immunosuppressive treatments.

5. Patients requiring regular steroids at a dose higher than prednisolone 10mg/day (or equivalent).

6. Patients with clinically significant, progressive, and/or uncontrolled renal, hepatic, haematological, endocrine, pulmonary, cardiac, gastroenterological, or neurological disease.

7. Patients with a history of immune mediated (CNS) toxicity or ≥ Grade 2 diarrhoea/colitis caused by, , previous immunotherapy within the past 6 months.

8. Patients who are pregnant or breastfeeding.

9. Patients who have undergone major surgery in the previous 3 weeks.

10. 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).

11. Patients with a history of organ transplantation.

12. Patients who have previously received any investigational cell or gene therapies.

13. Patients with contraindications for protocol specified agents.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Achilles Therapeutics UK Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor, MD

Role: STUDY_DIRECTOR

Achilles Therapeutics UK Limited

Locations

Instituto de Investigación Sanitaria Fundación Jimenez Díaz

Madrid, , Spain

Centro Integral Oncologico Clara Campal (CIOCC) Hospital Universitario HM Sanchinarro

Madrid, , Spain

Cambridge University Hospitals NHS Foundation Trust, Addenbrookes Hospital

Cambridge, , United Kingdom

University College London Hospitals (UCLH) NHS Foundation Trust, University College Hospital

London, , United Kingdom

Royal Free London NHS Foundation Trust, Royal Free Hospital

London, , United Kingdom

Guys and St Thomas' NHS Foundation Trust, Guy's Hospital

London, , United Kingdom

The Royal Marsden NHS Foundation Trust, The Royal Marsden Hospital

London, , United Kingdom

The Christie NHS Foundation Trust, Christie Hospital

Manchester, , United Kingdom

The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital

Newcastle upon Tyne, , United Kingdom

University Hospital Southampton NHS Foundation Trust, Southampton General Hospital

Southampton, , United Kingdom

Countries

Spain; United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

ATX-ME-001

Identifier Type: -

Identifier Source: org_study_id