ATL001 in Patients With Advanced Unresectable or Metastatic NSCLC

Stopped early · Phase 1/Phase 2

Conditions studied: Advanced Non Small Cell Lung Cancer

In brief

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).

Key facts

Study ID

NCT04032847

Run by

Achilles Therapeutics UK Limited

People needed

27

Starts

2019-07-08

Expected to finish

2024-09-26

Last updated by the study team

2025-03-10

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient must be at 18-75 years old.
• Patients must have confirmed diagnosis of non-small cell lung cancer that is considered to be smoking related.
• Patient is considered medically fit to undergo procurement of starting material and ATL001 administration procedures.
• ECOG Performance Status 0-1.
• Adequate organ function per the laboratory parameters defined in the protocol.
• Anticipated life expectancy ≥ 6 months at the time of tissue procurement.
• Measurable disease according to RECIST 1.1 criteria.
• Additional Inclusion Criteria will apply as per the protocol.

You may not qualify if…

• 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.
• Patients with hepatitis B or C, human immunodeficiency virus infection (HIV1/2), syphilis or HTLVI/II infection.
• 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.
• Patients requiring immunosuppressive treatments.
• Patients requiring regular steroids at dose higher than prednisolone 10mg/day (or equivalent)
• Patients with superior vena cava syndrome.
• Patients with clinically significant, progressive, and/or uncontrolled renal, hepatic, haematological, endocrine, pulmonary, cardiac, gastroenterological or neurological disease.
• 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.
• 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)
• Patients with a history of organ transplantation
• Patients who have previously received any investigational cell or gene therapies
• Additional Exclusion Criteria will apply as per the protocol.

Where it is running

• 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

Full record on ClinicalTrials.gov

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