Long-Term Follow-Up Study of Patients Receiving ATL001

NCT ID: NCT04785365

Last Updated: 2023-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-10-18

Brief Summary

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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

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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.

Conditions

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Melanoma Advanced Non Small Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Biological: ATL001

Intervention Type OTHER

No investigational product will be administered

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

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

Group Type OTHER

Biological: ATL001

Intervention Type OTHER

No investigational product will be administered

Interventions

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Biological: ATL001

No investigational product will be administered

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Achilles Therapeutics UK Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor, MD

Role: STUDY_DIRECTOR

Achilles Therapeutics UK Limited

Locations

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

London, , United Kingdom

Site Status

Countries

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United Kingdom

Related Links

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Other Identifiers

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ATX-LTFU-001

Identifier Type: -

Identifier Source: org_study_id

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