ATL001 in Patients With Advanced Unresectable or Metastatic NSCLC
This is a first-in-human, open-label, multi-centre, phase I/IIa study to characterise the safety and clinical activity autologous clonal neoantigen reactive T cells (cNeT) administered intravenously in adults with advanced non-small cell lung cancer (NSCLC).
Checked against the public recordLast updated Mar 10, 2025 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- Achilles Therapeutics UK Limited
- Interventions being studied
- Biological: ATL001; Drug: Pembrolizumab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: 1. Patient must be at 18-75 years old. 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. Additional Inclusion Criteria will apply as per the protocol. Exclusion Criteria: 1. Patients with untreated, symptomatic or progressing CNS metastases. Lesions should be clinically and radiologically stable for 2 months after treatment and should not require steroids. 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 Additional Exclusion Criteria will apply as per the protocol.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Yale University School of MedicineNew Haven, Connecticut
- Moffitt Cancer CenterTampa, Florida
- Memorial Sloan Kettering Cancer CenterNew York, New York
- Centre Hospitalier Lyon SudPierre-Bénite
- Universitätsklinikum Carl Gustav Carus DresdenDresden
- Universitätsklinikum EssenEssen
- Hospital Clinic de BarcelonaBarcelona, Catalonia
- Instituto de Investigación Sanitaria Fundación Jimenez DíazMadrid
- Centro Integral Oncologico Clara Campal Hospital Universitario HM SanchinarroMadrid
- Hospital Clinico Universitario de ValenciaValencia
- University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth HospitalBirmingham
- Cambridge University Hospitals NHS Foundation Trust, Addenbrookes HospitalCambridge
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 10, 2025. Always confirm current availability with the study team.