Long-Term Follow-Up Study of Patients Receiving ATL001

Achilles Therapeutics

Status and phase: Terminated; Phase 2

Conditions: Melanoma; Advanced Non Small Cell Lung Cancer

Treatments: Other: Biological: ATL001

Study type: Interventional

Funder types: Industry

Identifiers

NCT04785365

ATX-LTFU-001

Details and patient eligibility

About

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).

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

Experimental: ATL001

Other group

Description:

Patients who have previously received ATL001 in a clinical trial will be evaluated in this trial for long-term safety and clinical activity.

Treatment:

Other: Biological: ATL001

Patients who have previously received ATL001 in study ATX-NS-001 or study ATX-ME-001

Other group

Description:

Patients who have previously received ATL001 in study ATX-NS-001 or study ATX-ME-001

Treatment:

Other: Biological: ATL001