ATL001 in Patients With Metastatic or Recurrent Melanoma
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|ClinicalTrials.gov Identifier: NCT03997474|
Recruitment Status : Recruiting
First Posted : June 25, 2019
Last Update Posted : July 29, 2021
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Biological: ATL001 Drug: Checkpoint Inhibitor||Phase 1 Phase 2|
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 then be requested to enter a separate long term follow up protocol for a further 5 years (total 84 months)
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||August 15, 2019|
|Estimated Primary Completion Date :||July 1, 2023|
|Estimated Study Completion Date :||December 31, 2023|
Experimental: Cohort A
Following lymphodepletion, infusion of cell therapy product ATL001, followed by a low dose regimen of IL- 2.
Experimental: 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.
Drug: Checkpoint Inhibitor
Experimental: Cohort C
Following lymphodepletion, infusion of cell therapy product ATL001, followed by a higher dose regimen of IL-2.
- Assessment of Treatment Emergent Adverse Events to evaluate Safety and Tolerability: CTCAE [ Time Frame: Maximum 84 month ]Evaluate treatment-emergent adverse events (TEAEs) and serious AEs, per CTCAE, by incidence, severity and relationship to ATL001
- 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 ]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).
- Disease Assessment for Overall Response Rate [ Time Frame: Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months ]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).
- 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 ]Evaluate the endpoints of time to response and duration of response (DOR) by the investigator and ICR, per RECIST v1.1 and im-RECIST.
- Disease Assessment for Disease Control Rate [ Time Frame: Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months ]Evaluate the endpoints of disease control rate (DCR) as assessed by the investigator and ICR per RECIST v1.1 and im-RECIST.
- Disease Assessment for Progression-Free Survival [ Time Frame: Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months ]Evaluate the efficacy endpoints of progression-free survival (PFS) as assessed by the investigator and ICR per RECIST v1.1 and im-RECIST.
- Overall survival [ Time Frame: Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months ]Evaluate overall survival (OS) by investigator
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03997474
|Contact: Senior VP, Clinical Operations Achilles Therapeutics, PhD||+44 (0)208 154 email@example.com|
|Cambridge University Hospitals NHS Foundation Trust||Recruiting|
|Cambridge, United Kingdom|
|Contact: Brent O'Carrigan, MD|
|University College London Hospital (UCLH)||Not yet recruiting|
|London, United Kingdom, NW12PG|
|Contact: Heather Shaw, MD|
|Guys and St Thomas' NHS Foundation Trust||Not yet recruiting|
|London, United Kingdom, SE19RT|
|Contact: Sophie Papa, MD|
|The Royal Marsden NHS Foundation Trust||Recruiting|
|London, United Kingdom, SW3 6JJ|
|Contact: Samra Turajlic, MD|
|The Christie NHS Foundation Trust||Recruiting|
|Manchester, United Kingdom, M20 4BX|
|Contact: Fiona Thistlethwaite, MD|
|Newcastle Upon Tyne, United Kingdom, NE7 7DN|
|Contact: Prof Ruth Plummer, MD|
|University Hospital Southampton NHS Foundation Trust||Recruiting|
|Southampton, United Kingdom|
|Contact: Ioannis Karydis, MD|
|Study Director:||Medical Monitor, MD||Achilles Therapeutics|