RecruitingInterventionalPhase 1

Long-Term Follow-Up (LTFU) of Participants Treated With ADP Adoptive Cell Therapies

NCT ID: NCT03391778Sponsor: USWM CT, LLCLast updated: 2026-03-03

Summary

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.

Detailed 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.

Arms & interventions

BiologicalADP adoptive cell therapy
No study drug is administered in this study. Participants who received ADP adoptive cell therapy in a previous trial will be evaluated in this trial for long-term safety and efficacy.

Outcome measures

Primary

Number of participants with delayed adverse events (AEs) and serious adverse events (SAEs)
AEs will be collected.
Time frame: 15 years post last treatment

Secondary

Number of participants with Vesicular Stomatitis Virus G protein (VSV-G) Deoxyribonucleic acid (DNA) copies in peripheral blood samples
Time frame: 15 years
Number of participants with Woodchuck hepatitis virus post-transcriptional regulatory element (WPRE) or Psi DNA copies in peripheral blood samples.
Time frame: 15 years
Number of participants with integrated vector sequences and vector integration patterns identified in peripheral blood samples
Time frame: 15 years
Number of deaths
Time frame: 15 years
Time to death
Time frame: 15 years

Eligibility criteria

Sex: AllAge: All agesHealthy volunteers: No

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 * Participants who have completed ADP sponsored or supported interventional study or have withdrawn from it.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

Study locations (13)

Emory University School of Medicine

Atlanta, Georgia, 30322

Recruiting

Clinical Trials Call Center · Contact

Melinda Yushak · Principal Investigator

ADP Investigational Site

Baltimore, Maryland, 21201

Recruiting

Clinical Trial Inquiries · Contact

Aaron Rapoport · Principal Investigator

National Cancer Institute - Center for Cancer Research

Bethesda, Maryland, 20892

Completed

University of Michigan

Ann Arbor, Michigan, 48109

Recruiting

Clinical Trial Inquiries · Contact

Rashmi Chugh · Principal Investigator

Washington University School of Medicine in St. Louis

St Louis, Missouri, 63110

Recruiting

Clinical Trial Inquiries · Contact

Brian Van Tine · Principal Investigator

Memorial Sloan Kettering Cancer Center - New York

New York, New York, 10065

Recruiting

MSKCC Clinical Trials Office · Contact

Sandra P D'Angelo · Principal Investigator

Duke University Medical Center

Durham, North Carolina, 27710

Recruiting

Clinical Trial Inquiries · Contact

Richard Riedel · Principal Investigator

Oregon Health and Science University

Portland, Oregon, 97239

Recruiting

Clinical Trial Inquiries · Contact

Lara Davis · Principal Investigator

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Recruiting

Clinical Trial Inquiries · Contact

Edward A Stadtmauer · Principal Investigator

University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232

Recruiting

Clinical Trial Inquiries · Contact

Melissa Burgess · Principal Investigator

University of Texas Southwestern Medical Center

Dallas, Texas, 75390

Recruiting

Clinical Trial Inquiries · Contact

John Samuel · Principal Investigator

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

Recruiting

Clinical Trial Inquiries · Contact

Dejka Araujo · Principal Investigator

Froedtert Hospital

Milwaukee, Wisconsin, 53226

Recruiting

Clinical Trial Inquiries · Contact

John A Charlson · Principal Investigator