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Recruiting Phase 1 NCT03391778

Adoptive Cell Therapy Long-term Follow-up (LTFU) Study

Phase 1 – testing safety in a small group of people
Conditions: Neoplasms

Sponsor: USWM CT, LLC

trial.available_in: БГ
Overview
This trial will evaluate long term safety of participants who have received AdaptImmune (ADP) adoptive cell therapy for up to 15 years following last adoptive cell therapy infusion.
Description
Participants who received a ADP adoptive cell therapy will be enrolled in this non-therapeutic, multi-center, long term follow-up (LTFU) study and will be followed for up to 15 years post-infusion of lentiviral vector-based adoptive cell therapy. Participants will be monitored for safety following last adoptive cell therapy infusion.
Who can participate
Inclusion Criteria: * Participants who have received at least one dose of ADP adoptive cell therapy agent. * Participants who have completed ADP sponsored or supported interventional study or have withdrawn from it. * Participants who have completed treatment as part of managed access to a GSK adoptive cell therapy. * Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * The investigator is responsible for review of medical history. * Capable of giving signed informed consent. Exclusion Criteria: \- None
Locations 8
Australia (1)
Peter MacCallum Cancer Centre
Melbourne , Victoria
Canada (1)
Princess Margaret Cancer Centre
Toronto , Ontario
Germany (1)
Klinikum rechts der Isar der Technischen Universität München
Munich , Bavaria
Italy (1)
Fondazione IRCCS - Istituto Nazionale dei Tumori
Milan , Lombardy
Netherlands (1)
Antoni Van Leeuwenhoek Ziekenhuis
Amsterdam
Spain (1)
Hospital Universitario Virgen del Rocío
Seville
United Kingdom (1)
University College London Hospitals NHS Foundation Trust
London
United States (1)
Emory University School of Medicine
Atlanta , Georgia
Technical details
Status
Recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Healthy volunteers
No
Start date
09.04.2018
Completion date
01.04.2032
Registry ID
NCT03391778
Source
anzctr
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