TerminatedPhase 1 / Phase 2NCT04032847
Official study title

ATL001 in Patients With Advanced Unresectable or Metastatic NSCLC

Study summary

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).

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedATL001 and Pembrolizumab

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Early-stage or resectable · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Mar 10, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?19 U.S. locations

Locations may change over time.

Who runs it?Achilles Therapeutics UK Limited

Study sponsor

01
Study overview

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
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Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

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.

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