Long-Term Follow-Up Study of Patients Receiving ATL001

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

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).

Study Overview

• Status: Terminated
• Conditions: Melanoma; Advanced Non Small Cell Lung Cancer
• Intervention / Treatment: Other: Biological: ATL001

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Senior VP Clinical Operations Achilles Therapeutics, PhD; Phone Number: +44 (0)208 154 4600; Email: info@achillestx.com

Study Locations

• United Kingdom
  • London, United Kingdom, NW12PG
    • University College London Hospital (UCLH) NHS Foundation Trust, University College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Experimental: ATL001; Patients who have previously received ATL001 in a clinical trial will be evaluated in this trial for long-term safety and clinical activity.	Other: Biological: ATL001; No investigational product will be administered
Other: Patients who have previously received ATL001 in study ATX-NS-001 or study ATX-ME-001	Other: Biological: ATL001; No investigational product will be administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
Disease Assessment for Time to First Subsequent anti-cancer Therapy (TFST)	Evaluate the endpoint of TFST	Maximum 60 months.
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
Assessment for cancer-related medical resources	Evaluate the endpoint of cancer-related medical resourcesATL001 therapy	Maximum 60 months.

Collaborators and Investigators

• Sponsor: Achilles Therapeutics UK Limited
• Investigators: Study Director: Medical Monitor, MD, Achilles Therapeutics UK Limited

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): October 18, 2023
• Study Completion (Actual): October 18, 2023

Study Registration Dates

• First Submitted: March 1, 2021
• First Submitted That Met QC Criteria: March 4, 2021
• First Posted (Actual): March 5, 2021

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 17, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: ATX-LTFU-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No