Long-Term Follow-Up Study of Patients Receiving ATL001

Phase 2TerminatedNCT04785365

Achilles Therapeutics UK Limited1 enrolled

Overview

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).

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

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Melanoma Advanced Non Small Cell Lung Cancer

Interventions

Biological: ATL001OTHER

No investigational product will be administered

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University College London Hospital (UCLH) NHS Foundation Trust, University College Hospital

London, United Kingdom

Outcomes

Primary Outcomes

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

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.

Assessment of autoimmune adverse events

Evaluate the frequency and severity 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.

Assessment of new malignancies

Evaluate the frequency and severity 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.

Assessment of the use of medications to manage ATL001-related toxicities

Evaluate 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.

Secondary Outcomes

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

Time frame: 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

Time frame: Maximum 60 months.

Data from ClinicalTrials.gov

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