Spots Global Cancer Trial Database for ATL001 in Patients With Metastatic or Recurrent Melanoma
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Trial Identification
Brief Title: ATL001 in Patients With Metastatic or Recurrent Melanoma
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 Metastatic or Recurrent Melanoma
Study ID: NCT03997474
Conditions
Study Description
Brief Summary: This is a first-in-human, open-label, multi-centre, phase I/IIa study to characterize the safety and clinical activity of ATL001, autologous clonal neoantigen reactive T cells (cNeT) administered intravenously in adults with metastatic or recurrent melanoma.
Detailed Description: This is a first-in-human, open-label, multi-centre, phase I/IIa study to characterize the safety and clinical activity autologous clonal neoantigen reactive T cells (cNeT) administered intravenously in adults with metastatic or recurrent melanoma. 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 be followed up for a period of 24 months post ATL001 infusion in the study. 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
Instituto de Investigación Sanitaria Fundación Jimenez Díaz, Madrid, , Spain
Centro Integral Oncologico Clara Campal (CIOCC) Hospital Universitario HM Sanchinarro, Madrid, , Spain
Cambridge University Hospitals NHS Foundation Trust, Addenbrookes Hospital, Cambridge, , United Kingdom
University College London Hospitals (UCLH) NHS Foundation Trust, University College Hospital, London, , United Kingdom
Royal Free London NHS Foundation Trust, Royal Free Hospital, London, , United Kingdom
Guys and St Thomas' NHS Foundation Trust, Guy's Hospital, London, , United Kingdom
The Royal Marsden NHS Foundation Trust, The Royal Marsden Hospital, London, , United Kingdom
The Christie NHS Foundation Trust, Christie 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 UK Limited
Role: STUDY_DIRECTOR
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