An Open-Label, Multi-Centre Phase II Study Evaluating the Long-Term Safety and Clinical Activity of Neoantigen Reactive T Cells in Patients Who Have Previously Received ATL001 in a Clinical Trial
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Melanoma
- Sponsor
- Achilles Therapeutics UK Limited
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Assessment of new malignancies
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
Brief Summary
This is an Open-Label, Multi-Centre Phase II study to evaluate the long-term safety and clinical activity of ATL001, previously administered intravenously to patients in Study ATX-NS-001 (NCT04032847) or Study ATX-ME-001 (NCT03997474).
Detailed Description
Up to 90 patients with advanced non-small cell lung cancer ( NSCLC) or metastatic or recurrent melanoma will be enrolled after either: completing 2 years of follow-up visits in study ATX-NS-001 or study ATX-ME-001; or voluntary withdrawal from these studies prior to the completion of the 2 year of follow-up period. Each patient will be followed up for a minimum period of 5 years, or until death if sooner, in this Long-Term Follow Up Protocol. For patients who are still alive after 5 years of follow-up, survival data will continue to be collected until the end of the study, which will occur when the last patient has completed 5 years of follow-up withdraws from study or has died.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients must have given written informed consent to participate in the study.
- •Patients must have received ATL001 in a previous Clinical Trial.
- •Patients must be considered, in the opinion of the Investigator, capable of complying with the protocol requirements.
Exclusion Criteria
- •There are no exclusion criteria.
Outcomes
Primary Outcomes
Assessment of new malignancies
Time Frame: Every 4 months to 60 months; then every 6 months until death or until the end of the study, whichever came first, assessed up to 84 months.
Evaluate the frequency and severity of new malignancies
Assessment of autoimmune adverse events
Time Frame: Every 4 months to 60 months; then every 6 months until death or until the end of the study, whichever came first, assessed up to 84 months.
Evaluate the frequency and severity of autoimmune adverse events
Assessment of the use of medications to manage ATL001-related toxicities
Time Frame: Every 4 months to 60 months; then every 6 months until death or until the end of the study, whichever came first, assessed up to 84 months.
Evaluate the use of medications to manage ATL001-related toxicities
Assessment of adverse events to evaluate long-term Safety and Tolerability of ATL001
Time Frame: Every 4 months to 60 months; then every 6 months until death or until the end of the study, whichever came first, assessed up to 84 months.
Evaluate the frequency and severity of adverse events related or possibly related to ATL001
Secondary Outcomes
- Disease Assessment for Progression Free Survival (PFS)(Maximum 60 months.)
- Assessment for Overall Survival (OS)(6 months until death or until the end of the study, whichever came first, assessed up to 84 months)
- Assessment for cancer-related medical resources(Maximum 60 months.)
- Disease Assessment for Duration of Response ( DoR)(Maximum 60 months.)
- Disease Assessment for Time to First Subsequent anti-cancer Therapy (TFST)(Maximum 60 months.)