MelanomaPhase 1/2NCT03997474
ATL001 in Patients With Metastatic or Recurrent Melanoma
A Phase 1/2 study testing ATL001 and Checkpoint Inhibitor in people with Melanoma, run by Achilles Therapeutics UK Limited at 10 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Melanoma
- What is being tested?
- ATL001 and Checkpoint Inhibitor
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 15 Aug 2019to 3 Sep 2024
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Additional Exclusion criteria will apply as per the study protocol.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United Kingdom8 sites
Cambridge University Hospitals NHS Foundation Trust, Addenbrookes Hospital
Cambridge, CB2 0QQ
University College London Hospitals (UCLH) NHS Foundation Trust, University College Hospital
London, NW12PG
Royal Free London NHS Foundation Trust, Royal Free Hospital
London, NW3 2QG
Guys and St Thomas' NHS Foundation Trust, Guy's Hospital
London, SE19RT
The Royal Marsden NHS Foundation Trust, The Royal Marsden Hospital
London, SW3 6JJ
The Christie NHS Foundation Trust, Christie Hospital
Manchester, M20 4BX
The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital
Newcastle upon Tyne, NE7 7DN
University Hospital Southampton NHS Foundation Trust, Southampton General Hospital
Southampton, SO16 6YD
Spain2 sites
Instituto de Investigación Sanitaria Fundación Jimenez Díaz
Madrid, 28040
Centro Integral Oncologico Clara Campal (CIOCC) Hospital Universitario HM Sanchinarro
Madrid, 28050
About this study
Official title: 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
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.
Read the 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
- Being tested
- ATL001, Checkpoint Inhibitor
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATL001Biological
ATL001 infusion
Checkpoint InhibitorDrug
Nivolumab
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | Following lymphodepletion, infusion of cell therapy product ATL001, followed by a low dose regimen of IL- 2. Receives: Biological: ATL001 |
| Cohort B | Experimental | Following lymphodepletion, infusion of cell therapy product ATL001 in combination with a checkpoint inhibitor, followed by a low dose regimen of IL-2. Receives: Biological: ATL001; Drug: Checkpoint Inhibitor |
| Cohort C | Experimental | Following lymphodepletion, infusion of cell therapy product ATL001, followed by a higher dose regimen of IL-2. Receives: Biological: ATL001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE
Evaluate treatment-emergent adverse events (TEAEs) and serious AEs, per CTCAE, by incidence, severity and relationship to ATL001
Measured: 60 months due to early termination
Secondary outcomes (6)
Disease Assessment for Change From Baseline in Tumour Size
Evaluate the clinical activity of ATL001 in patients with recurrent or metastatic melanoma using change from baseline in tumour size at week 6, week 12 and best overall change from baseline, as assessed by investigator and independent central review (ICR).
Measured: Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months
Disease Assessment for Overall Response Rate
Evaluate the endpoint of overall response rate (ORR), as assessed by investigator and ICR, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and immune modified RECIST( im-RECIST).
RECIST v1.1 (Response Evaluation Criteria in Solid Tumors) is a standardized system for measuring tumor response to treatment in clinical trials. Tumors are assessed by imaging (e.g., CT or MRI) based on changes in size. Responses are categorized as:
Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): ≥30% reduction in the sum of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD).
Progressive Disease (PD): ≥20% increase in the sum of target lesions, or appearance of new lesions.
These criteria help assess the efficacy of treatments in solid tumors supported by im-RECIST in immunotherapy.
Measured: Every 6 weeks for 6 months, then every 3 months (up to 60 months due to early study termination)
Disease Assessment for Time to Response and Duration of Response
Evaluate the endpoints of time to response and duration of response (DOR) by the investigator and ICR, per RECIST v1.1 and im-RECIST.
Measured: Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months
Disease Assessment for Disease Control Rate
Evaluate the endpoints of disease control rate (DCR) as assessed by the investigator and ICR per RECIST v1.1 and im-RECIST.
Measured: Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months
Disease Assessment for Progression-Free Survival
Evaluate the efficacy endpoints of progression-free survival (PFS) as assessed by the investigator and ICR per RECIST v1.1 and im-RECIST.
Measured: Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months
Overall Survival
Evaluate overall survival (OS) by investigator
Measured: Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start15 Aug 2019
- Primary completion3 Sep 2024
- Study completion3 Sep 2024
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Achilles Therapeutics UK Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, MD, Study director, Achilles Therapeutics UK Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03997474
- Sponsor's protocol ID
- ATX-ME-001
- Status last verified
- Feb 2025
- First submitted
- 4 Feb 2019
- Last updated
- 7 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03997474
- Acronym / sponsor ID
- ATX-ME-001
- Conditions
- Melanoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Achilles Therapeutics UK LimitedIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 3 Sep 2024 (actual)
- Study completion
- 3 Sep 2024 (actual)
- First posted
- 25 Jun 2019 (actual)
- Results
- Posted 7 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Biological: ATL001Following lymphodepletion, infusion of cell therapy product ATL001, followed by a low dose regimen of IL- 2. |
| Cohort B | Experimental | Biological: ATL001, Drug: Checkpoint InhibitorFollowing lymphodepletion, infusion of cell therapy product ATL001 in combination with a checkpoint inhibitor, followed by a low dose regimen of IL-2. |
| Cohort C | Experimental | Biological: ATL001Following lymphodepletion, infusion of cell therapy product ATL001, followed by a higher dose regimen of IL-2. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (14 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATL001ATL001 infusion | Biological | Cohort A, Cohort B, Cohort C |
| Checkpoint InhibitorNivolumab | Drug | Cohort B |
Primary outcome
Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE
Time frame: 60 months due to early termination
Evaluate treatment-emergent adverse events (TEAEs) and serious AEs, per CTCAE, by incidence, severity and relationship to ATL001
6 secondary outcomes
Disease Assessment for Change From Baseline in Tumour Size
Time frame: Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months
Disease Assessment for Overall Response Rate
Time frame: Every 6 weeks for 6 months, then every 3 months (up to 60 months due to early study termination)
Disease Assessment for Time to Response and Duration of Response
Time frame: Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months
Disease Assessment for Disease Control Rate
Time frame: Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months
Disease Assessment for Progression-Free Survival
Time frame: Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months
Overall Survival
Time frame: Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor, MD study director
Achilles Therapeutics UK Limited
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ATL001 and Checkpoint Inhibitor in people with Melanoma, run by Achilles Therapeutics UK Limited at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United Kingdom, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE (time frame: 60 months due to early termination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.