Long-Term Follow-Up Study of Patients Receiving ATL001

Melanoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04785365
• Other study ID #: ATX-LTFU-001
• Status: Terminated
• Phase: Phase 2
• Start date: June 1, 2022
• Est. completion date: October 18, 2023

Study information

• Verified date: November 2023
• Source: Achilles Therapeutics UK Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: October 18, 2023
• Est. primary completion date: October 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Non Small Cell Lung Cancer
• Carcinoma, Non-Small-Cell Lung
• Melanoma

Intervention

Other:
• Biological: ATL001
No investigational product will be administered

Locations

Country	Name	City	State
United Kingdom	University College London Hospital (UCLH) NHS Foundation Trust, University College Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Achilles Therapeutics UK Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of adverse events to evaluate long-term Safety and Tolerability of ATL001	Evaluate the frequency and severity of adverse events related or possibly related to ATL001	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.
Primary	Assessment of autoimmune adverse events	Evaluate the frequency and severity of autoimmune adverse events	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.
Primary	Assessment of new malignancies	Evaluate the frequency and severity of new malignancies	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.
Primary	Assessment of the use of medications to manage ATL001-related toxicities	Evaluate the use of medications to manage ATL001-related toxicities	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	Disease Assessment for Duration of Response ( DoR)	Evaluate the endpoint of DoR as assessed by the Investigator and Independent Central Review (ICR), per RECIST v1.1	Maximum 60 months.
Secondary	Disease Assessment for Progression Free Survival (PFS)	Evaluate the endpoint of PFS as assessed by the Investigator and ICR, per RECIST v1.1	Maximum 60 months.
Secondary	Disease Assessment for Time to First Subsequent anti-cancer Therapy (TFST)	Evaluate the endpoint of TFST	Maximum 60 months.
Secondary	Assessment for Overall Survival (OS)	Evaluate the endpoint of OS by the Investigator	6 months until death or until the end of the study, whichever came first, assessed up to 84 months
Secondary	Assessment for cancer-related medical resources	Evaluate the endpoint of cancer-related medical resourcesATL001 therapy	Maximum 60 months.

External Links

•   ATX-ME-001 Clinicaltrials.gov
•   ATX-NS-001 Clinicaltrials.gov