Long-term follow-up for patients who received adoptive cell therapy
Long-Term Follow-Up (LTFU) of Participants Treated With ADP Adoptive Cell Therapies
This study looks at the long-term safety of patients who received a special cell therapy to see how they are doing up to 15 years later.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Sex | All |
| Sponsor | USWM, LLC (dba US WorldMeds) Industry-sponsored |
| Locations | 24 sites (Atlanta, Georgia and 23 other locations) |
| Trial ID | NCT03391778 on ClinicalTrials.gov |
What this trial studies
This study evaluates the long-term safety of participants who have undergone AdaptImmune's adoptive cell therapy. It is a non-therapeutic, multi-center follow-up study that will monitor participants for up to 15 years after their last infusion of lentiviral vector-based therapy. The focus is on assessing any safety concerns that may arise during this extended period.
Who should consider this trial
Good fit: Ideal candidates are individuals who have previously received at least one dose of AdaptImmune's adoptive cell therapy.
Not a fit: Patients who have not received AdaptImmune's adoptive cell therapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term safety of adoptive cell therapy, helping to inform future treatments.
How similar studies have performed: While this study focuses on long-term follow-up, similar studies have shown the importance of monitoring safety in adoptive cell therapies, indicating a potential for valuable findings.
Eligibility criteria
Show full inclusion / exclusion criteria
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 * Participants who have completed ADP sponsored or supported interventional study or have withdrawn from it.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
Where this trial is running
Atlanta, Georgia and 23 other locations
- Emory University School of Medicine — Atlanta, Georgia, United States (Recruiting)
- ADP Investigational Site — Baltimore, Maryland, United States (Recruiting)
- National Cancer Institute - Center for Cancer Research — Bethesda, Maryland, United States (Completed)
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
- Washington University School of Medicine in St. Louis — St Louis, Missouri, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center - New York — New York, New York, United States (Recruiting)
- Duke University Medical Center — Durham, North Carolina, United States (Recruiting)
- Oregon Health and Science University — Portland, Oregon, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center — Pittsburgh, Pennsylvania, United States (Recruiting)
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
- University of Texas MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- Froedtert Hospital — Milwaukee, Wisconsin, United States (Recruiting)
- Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia (Recruiting)
- Princess Margaret Cancer Centre — Toronto, Ontario, Canada (Recruiting)
- Hôpital Maisonneuve-Rosemont — Montreal, Quebec, Canada (Recruiting)
- Klinikum rechts der Isar der Technischen Universität München — Munich, Bavaria, Germany (Recruiting)
- Uniklinik Köln — Cologne, North Rhine-Westphalia, Germany (Recruiting)
- Fondazione IRCCS - Istituto Nazionale dei Tumori — Milan, Lombardy, Italy (Recruiting)
- Antoni Van Leeuwenhoek Ziekenhuis — Amsterdam, Netherlands (Recruiting)
- Hospital Universitario Virgen del Rocío — Seville, Spain (Recruiting)
- University College London Hospitals NHS Foundation Trust — London, United Kingdom (Recruiting)
- USWM CT Investigational Site — Manchester, United Kingdom (Recruiting)
- The Royal Marsden NHS Foundation Trust — Sutton, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Investigator Study Inquiries LTFU
- Email: Clinicaltrials2@usworldmeds.com
- Phone: 866-750-8796
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.