ATL001 in Patients With Advanced Unresectable or Metastatic NSCLC
NCT ID: NCT04032847
Last Updated: 2025-03-10
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
27 participants
INTERVENTIONAL
2019-07-08
2024-09-26
Brief Summary
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Detailed Description
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Patients will initially enter the study for procurement of tumour materials required to manufacture ATL001.
Following manufacture of ATL001, the product will be given back to eligible patients following lymphodepletion. Patients will continue to be followed up for a minimum of 5 years, as part of a separate Long Term Follow Up Protocol, or, if the separate protocol is not available at the study site, within this protocol.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort A
Following lymphodepletion with enhanced host conditioning, infusion of cell therapy product ATL001, followed by a low dose regimen of IL- 2.
ATL001
ATL001 infusion
Cohort B
Following lymphodepletion with enhanced host conditioning, infusion of cell therapy product ATL001 in combination with a checkpoint inhibitor, followed by a low dose regimen of IL- 2.
ATL001
ATL001 infusion
Pembrolizumab
Checkpoint inhibitor
Cohort C
Following lymphodepletion with enhanced host conditioning, infusion of cell therapy product ATL001, followed by a higher dose regimen of IL-2.
ATL001
ATL001 infusion
Interventions
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ATL001
ATL001 infusion
Pembrolizumab
Checkpoint inhibitor
Eligibility Criteria
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Inclusion Criteria
2. Patients must have confirmed diagnosis of non-small cell lung cancer that is considered to be smoking related.
3. Patient is considered medically fit to undergo procurement of starting material and ATL001 administration procedures.
4. ECOG Performance Status 0-1.
5. Adequate organ function per the laboratory parameters defined in the protocol.
6. Anticipated life expectancy ≥ 6 months at the time of tissue procurement.
7. Measurable disease according to RECIST 1.1 criteria.
Exclusion Criteria
2. Patients with hepatitis B or C, human immunodeficiency virus infection (HIV1/2), syphilis or HTLVI/II infection.
3. Patients for whom there is documented evidence of an actionable tumour driver oncogene mutation (EGFR, ALK or ROS-1) at the time of initial screening. Patients who have progressed on standard targeted therapies, or for whom no approved targeted treatments are available, are not excluded.
4. Patients requiring immunosuppressive treatments.
5. Patients requiring regular steroids at dose higher than prednisolone 10mg/day (or equivalent)
6. Patients with superior vena cava syndrome.
7. Patients with clinically significant, progressive, and/or uncontrolled renal, hepatic, haematological, endocrine, pulmonary, cardiac, gastroenterological or neurological disease.
8. Patients with a history of immune mediated central nervous system toxicity, or a history of ≥ Grade 2 diarrhoea/colitis within the past 6 months caused by previous immunotherapy.
9. Patients with an active concurrent cancer or a history of cancer within the past 3 years (except for in situ carcinomas, early prostate cancer with normal Prostate- Specific Antigen (PSA) or non-melanomatous skin cancers)
10. Patients with a history of organ transplantation
11. Patients who have previously received any investigational cell or gene therapies
18 Years
75 Years
ALL
No
Sponsors
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Achilles Therapeutics UK Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor, MD
Role: STUDY_DIRECTOR
Achilles Therapeutics
Locations
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Yale University School of Medicine
New Haven, Connecticut, United States
Moffitt Cancer Center
Tampa, Florida, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, , Germany
Universitätsklinikum Essen
Essen, , Germany
Hospital Clinic de Barcelona
Barcelona, Catalonia, Spain
Instituto de Investigación Sanitaria Fundación Jimenez Díaz
Madrid, , Spain
Centro Integral Oncologico Clara Campal Hospital Universitario HM Sanchinarro
Madrid, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital
Birmingham, , United Kingdom
Cambridge University Hospitals NHS Foundation Trust, Addenbrookes Hospital
Cambridge, , United Kingdom
The Leeds Teaching Hospitals NHS Trust, St James's University Hospital
Leeds, , United Kingdom
University College London Hospitals (UCLH) NHS Foundation Trust, University College Hospital
London, , United Kingdom
Guys and St Thomas' NHS Foundation Trust, Guy's Hospital
London, , United Kingdom
The Christie NHS Foundation Trust, Christie Hospital
Manchester, , United Kingdom
Manchester University NHS Foundation Trust, Wythenshawe Hospital
Manchester, , United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital
Newcastle upon Tyne, , United Kingdom
University Hospital Southampton NHS Foundation Trust, Southampton General Hospital
Southampton, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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ATX-NS-001
Identifier Type: -
Identifier Source: org_study_id
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