ATL001 in Patients With Metastatic or Recurrent Melanoma
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|ClinicalTrials.gov Identifier: NCT03997474|
Recruitment Status : Not yet recruiting
First Posted : June 25, 2019
Last Update Posted : July 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Biological: ATL001||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 (cNeTs) administered intravenously in adults with metastatic or recurrent melanoma.
Patients will be screened for eligibility and consented to the study. Following donation and subsequent 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. After 2 years each patient will continue to be followed for a further 5 years as part of separate Long Term Follow-Up protocol.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group 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|
|Estimated Study Start Date :||August 15, 2019|
|Estimated Primary Completion Date :||October 31, 2022|
|Estimated Study Completion Date :||October 31, 2022|
Experimental: Arm 1
Infusion of ATL001
- Assessment of Treatment Emergent Adverse Events to evaluate Safety and Tolerability: CTCAE v 4.0 [ Time Frame: Maximum 84 month ]Evaluate treatment-emergent adverse events (TEAEs) and serious AEs, per CTCAE v 4.0, 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 Objective Response Rate [ Time Frame: Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months ]Evaluate the endpoint of objective 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: Until death up to 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: VP, Clinical Operations Achilles Therapeutics, PhD||+44(0)1438 906 firstname.lastname@example.org|
|Study Director:||Medical Monitor, MD||Achilles Therapeutics|