Clinical trial NCT04785365: Long-Term Follow-Up Study of Patients Receiving ATL001
Official 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Melanoma
Advanced Non Small Cell Lung Cancer
Lead sponsor: Achilles Therapeutics UK Limited
Sponsor class: INDUSTRY
First posted: 2021-03-05
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

1. Patients must have given written informed consent to participate in the study.
2. Patients must have received ATL001 in a previous Clinical Trial.
3. Patients must be considered, in the opinion of the Investigator, capable of complying with the protocol requirements.

Exclusion Criteria:

There are no exclusion criteria.

Primary outcomes:
measure: Assessment of adverse events to evaluate long-term Safety and Tolerability of ATL001
timeFrame: 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.
measure: Assessment of autoimmune adverse events
timeFrame: 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.
measure: Assessment of new malignancies
timeFrame: 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.
measure: Assessment of the use of medications to manage ATL001-related toxicities
timeFrame: 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.
Secondary outcomes:
measure: Disease Assessment for Duration of Response ( DoR)
timeFrame: Maximum 60 months.
measure: Disease Assessment for Progression Free Survival (PFS)
timeFrame: Maximum 60 months.
measure: Disease Assessment for Time to First Subsequent anti-cancer Therapy (TFST)
timeFrame: Maximum 60 months.
measure: Assessment for Overall Survival (OS)
timeFrame: 6 months until death or until the end of the study, whichever came first, assessed up to 84 months
measure: Assessment for cancer-related medical resources
timeFrame: Maximum 60 months.
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London Hospital (UCLH) NHS Foundation Trust, University College Hospital
Study officials:
affiliation: Achilles Therapeutics UK Limited
name: Medical Monitor, MD
role: STUDY_DIRECTOR
References: