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Trial record 1 of 2 for:    ATX-NS-001
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Long-Term Follow-Up Study of Patients Receiving ATL001

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ClinicalTrials.gov Identifier: NCT04785365
Recruitment Status : Terminated (The long-term follow-up of patients is being migrated to the original (parent) study protocols (Trial ID: ATX-NS-001 / NCT: NCT04032847;Trial ID: ATX-ME-001 / NCT: NCT03997474). Consequently, the ATX-LTFU-001 study is being terminated by the Sponsor.)
First Posted : March 5, 2021
Last Update Posted : November 21, 2023
Sponsor:
Information provided by (Responsible Party):
Achilles Therapeutics UK Limited

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Melanoma Advanced Non Small Cell Lung Cancer Other: Biological: ATL001 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : June 1, 2022
Actual Primary Completion Date : October 18, 2023
Actual Study Completion Date : October 18, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
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
 Other: Biological: ATL001
No investigational product will be administered


Outcome Measures
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Primary Outcome Measures :
  1. Assessment of adverse events to evaluate long-term Safety and Tolerability of 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. ]
    Evaluate the frequency and severity of adverse events related or possibly related to ATL001

  2. Assessment 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. ]
    Evaluate the frequency and severity of autoimmune adverse events

  3. Assessment 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. ]
    Evaluate the frequency and severity of new malignancies

  4. Assessment of 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. ]
    Evaluate the use of medications to manage ATL001-related toxicities


Secondary Outcome Measures :
  1. Disease Assessment for Duration of Response ( DoR) [ Time Frame: Maximum 60 months. ]
    Evaluate the endpoint of DoR as assessed by the Investigator and Independent Central Review (ICR), per RECIST v1.1

  2. Disease Assessment for Progression Free Survival (PFS) [ Time Frame: Maximum 60 months. ]
    Evaluate the endpoint of PFS as assessed by the Investigator and ICR, per RECIST v1.1

  3. Disease Assessment for Time to First Subsequent anti-cancer Therapy (TFST) [ Time Frame: Maximum 60 months. ]
    Evaluate the endpoint of TFST

  4. Assessment for Overall Survival (OS) [ Time Frame: 6 months until death or until the end of the study, whichever came first, assessed up to 84 months ]
    Evaluate the endpoint of OS by the Investigator

  5. Assessment for cancer-related medical resources [ Time Frame: Maximum 60 months. ]
    Evaluate the endpoint of cancer-related medical resourcesATL001 therapy


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04785365


Locations
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United Kingdom
University College London Hospital (UCLH) NHS Foundation Trust, University College Hospital
London, United Kingdom, NW12PG
Sponsors and Collaborators
Achilles Therapeutics UK Limited
Investigators
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Study Director: Medical Monitor, MD Achilles Therapeutics UK Limited
More Information
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Additional Information:

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Responsible Party: Achilles Therapeutics UK Limited
ClinicalTrials.gov Identifier: NCT04785365    
Other Study ID Numbers: ATX-LTFU-001
First Posted: March 5, 2021    Key Record Dates
Last Update Posted: November 21, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases