Spots Global Cancer Trial Database for ATL001 in Patients With Advanced Unresectable or Metastatic NSCLC
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Trial Identification
Brief Title: ATL001 in Patients With Advanced Unresectable or Metastatic NSCLC
Official Title: An Open-Label, Multi-Centre Phase I/IIa Study Evaluating the Safety and Clinical Activity of Neoantigen Reactive T Cells in Patients With Advanced Non-Small Cell Lung Cancer
Study ID: NCT04032847
Conditions
Study Description
Brief 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).
Detailed Description: This is a first-in-human, open-label, multi-centre, phase I/IIa study to characterise the safety and clinical activity of autologous clonal neoantigen reactive T cells (cNeT) administered intravenously in adults with advanced non-small cell lung cancer (NSCLC). 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Duke University Medical Center, Durham, North Carolina, 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
Contact Details
Name: Medical Monitor, MD
Affiliation: Achilles Therapeutics
Role: STUDY_DIRECTOR
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