ATX-LTFU-001 - Long-Term Follow-Up of Patients Treated with ATL001
Research type
Research Study
Full title
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.
IRAS ID
295629
Contact name
Sean Russell
Contact email
Sponsor organisation
Achilles Therapeutics UK Limited
Eudract number
2020-003423-41
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
Research Summary:
This trial is an open-label, multi-centre phase II study evaluating the long-term safety and clinical activity of clonal neoantigen reactive T cells (cNeT) in patients who have previously received ATL001 in a clinical trial.
The primary objective of this trial is to assess the long-term safety and tolerability of ATL001 based on the frequency and severity of adverse events related to ATL001. The long-term clinical activity of ATL001 and requirement for cancer-related medical resources will also be evaluated as secondary objectives.
Additional exploratory endpoints will be evaluated to further characterize ATL001 for clinical development.
Patients 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 aforementioned studies prior to the completion of the 2 year follow-up period.
In this Long Term Follow Up Protocol, each patient will be followed up for a minimum period of 5 years, or until death if sooner.Lay summary of study results: For the whole duration of the study, 1 patient was enrolled onto the
ATX-LTFU-001 clinical study and has since been transferred back to the original parent clinical study as part of its Long Term Follow-Up.REC name
London - West London & GTAC Research Ethics Committee
REC reference
21/LO/0638
Date of REC Opinion
7 Dec 2021
REC opinion
Further Information Favourable Opinion