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

NCT03391778 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 208750ADP-0000-002
• Study Type: interventional
• Target: 250
• Locations: 8 countries
• Sites: 24

Brief 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.

Conditions

Neoplasms

Keywords

Long Term Follow Up; Adoptive Cell Therapy; Replication Competent Lentivirus

Outcome Measures

Primary Outcomes (1)

• Number of participants with delayed adverse events (AEs) and serious adverse events (SAEs)

  AEs will be collected.

  15 years post last treatment

Secondary Outcomes (5)

• Number of participants with Vesicular Stomatitis Virus G protein (VSV-G) Deoxyribonucleic acid (DNA) copies in peripheral blood samples

  15 years

• Number of participants with Woodchuck hepatitis virus post-transcriptional regulatory element (WPRE) or Psi DNA copies in peripheral blood samples.

  15 years

• Number of participants with integrated vector sequences and vector integration patterns identified in peripheral blood samples

  15 years

• Number of deaths

  15 years

• Time to death

  15 years

Study Arms (1)

Participants receiving ADP adoptive cell therapy

EXPERIMENTAL

Biological: ADP adoptive cell therapy

Interventions

ADP adoptive cell therapy BIOLOGICAL

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.

Participants receiving ADP adoptive cell therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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• Participants who have completed ADP sponsored or supported interventional study or have withdrawn from it.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

You may not qualify if:

• \- None

Sponsors & Collaborators

• USWM CT, LLC: lead

Study Sites (24)

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

RECRUITING

ADP Investigational Site

Baltimore, Maryland, 21201, United States

RECRUITING

National Cancer Institute - Center for Cancer Research

Bethesda, Maryland, 20892, United States

COMPLETED

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Washington University School of Medicine in St. Louis

St Louis, Missouri, 63110, United States

RECRUITING

Memorial Sloan Kettering Cancer Center - New York

New York, New York, 10065, United States

RECRUITING

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

Oregon Health and Science University

Portland, Oregon, 97239, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

RECRUITING

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

RECRUITING

Klinikum rechts der Isar der Technischen Universität München

Munich, Bavaria, 81377, Germany

RECRUITING

Uniklinik Köln

Cologne, North Rhine-Westphalia, 50937, Germany

RECRUITING

Fondazione IRCCS - Istituto Nazionale dei Tumori

Milan, Lombardy, 20133, Italy

RECRUITING

Antoni Van Leeuwenhoek Ziekenhuis

Amsterdam, 1066 CX, Netherlands

RECRUITING

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

RECRUITING

University College London Hospitals NHS Foundation Trust

London, NW1 2PG, United Kingdom

RECRUITING

USWM CT Investigational Site

Manchester, M20 4BX, United Kingdom

RECRUITING

The Royal Marsden NHS Foundation Trust

Sutton, SM2 5PT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Michael Nathenson, MD

  USWM CT, LLC

  STUDY DIRECTOR

Central Study Contacts

Investigator Study Inquiries LTFU

CONTACT

866-750-8796; Clinicaltrials2@usworldmeds.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2018
• First Posted: January 5, 2018
• Study Start: April 9, 2018
• Primary Completion (Estimated): April 1, 2032
• Study Completion (Estimated): April 1, 2032
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3); CA (2); IT (1); NL (1); DE (2); US (13); ES (1); AU (1)