Study on ATL001 for Patients with Advanced Non-Small Cell Lung Cancer (NSCLC)

Sponsor: Achilles Therapeutics UK Limited

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04032847

Provider View

This clinical trial is testing a new treatment called ATL001, which uses a patient's own modified immune cells to target advanced non-small cell lung cancer (NSCLC). The study aims to determine if this approach is safe and effective.

Patient Parameters

Program Overview

This study is exploring a new treatment for advanced non-small cell lung cancer (NSCLC) using a patient's own immune cells, which are modified in the lab to better target cancer cells. The main goals are to assess the safety of this treatment and to see if it can help control the cancer in adults aged 18 to 75. Participants will have their tumor material collected to create the ATL001 treatment, which will be given back to them after a preparation phase. They will be monitored for at least 5 years to track their health and the treatment's effects.

Description

This clinical trial is testing a new treatment called ATL001 for adults with advanced non-small cell lung cancer (NSCLC). The study involves collecting tumor samples from patients to create a personalized treatment using their own immune cells, which are modified to better attack cancer cells. This treatment is given back to the patient through an IV after a preparation phase to make the body ready for the new cells.

Participants will be closely monitored for safety and effectiveness of the treatment. The study will take place at multiple centers and will follow patients for at least 5 years to gather long-term data on their health and the treatment's impact. This trial is open-label, meaning both the researchers and participants know what treatment is being given.

Eligibility Criteria

Inclusion Criteria

  • Be between 18 and 75 years old.
  • Have a confirmed diagnosis of non-small cell lung cancer related to smoking.
  • Be medically fit to undergo the procedures needed for the treatment.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Have adequate organ function based on specific lab tests.
  • Have a life expectancy of at least 6 months at the time of tissue collection.
  • Have measurable cancer according to standard criteria.

Exclusion Criteria

  • Have untreated or worsening cancer that has spread to the brain.
  • Have infections like hepatitis B or C, HIV, syphilis, or HTLV.
  • Have a tumor with certain genetic mutations that can be targeted by other treatments, unless those treatments have failed.
  • Require immunosuppressive treatments or regular high-dose steroids.
  • Have superior vena cava syndrome.
  • Have significant, uncontrolled health issues affecting major organs.
  • Have a history of severe immune-related side effects from previous treatments.
  • Have another active cancer or a history of cancer within the past 3 years, except for certain early-stage cancers.
  • Have had an organ transplant.
  • Have previously received any investigational cell or gene therapies.

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