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

February 27, 2026 updated by: USWM CT, LLC

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3000
        • Recruiting
        • Peter MacCallum Cancer Centre
        • Principal Investigator:
          • Jayesh Desai
        • Contact:
          • Clinical Trial Inquiries
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Cancer Centre
        • Principal Investigator:
          • Adrian Sacher
        • Contact:
          • Clinical Trial Inquiries
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Recruiting
        • Hôpital Maisonneuve-Rosemont
        • Principal Investigator:
          • Jonathan Noujaim
        • Contact:
          • Clinical Trial Inquiries
  • Germany
    • Bavaria
      • Munich, Bavaria, Germany, 81377
        • Recruiting
        • Klinikum rechts der Isar der Technischen Universität München
        • Principal Investigator:
          • Lars Lindner
        • Contact:
          • Clinical Trial Inquiries
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Germany, 50937
        • Recruiting
        • Uniklinik Köln
        • Principal Investigator:
          • Roland Ullrich
        • Contact:
          • Clinical Trial Inquiries
  • Italy
    • Lombardy
      • Milan, Lombardy, Italy, 20133
        • Recruiting
        • Fondazione IRCCS - Istituto Nazionale dei Tumori
        • Principal Investigator:
          • Silvia Stacchiotti
        • Contact:
          • Clinical Trial Inquiries
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Recruiting
        • Antoni van Leeuwenhoek Ziekenhuis
        • Principal Investigator:
          • John B.A.G. Haanen
        • Contact:
          • Clinical Trial Inquiries
  • Spain
      • Seville, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocio
        • Principal Investigator:
          • Pilar Sancho Márquez
        • Contact:
          • Clinical Trial Inquiries
  • United Kingdom
      • London, United Kingdom, NW1 2PG
        • Recruiting
        • University College London Hospitals Nhs Foundation Trust
        • Principal Investigator:
          • Sandra Strauss
        • Contact:
          • Clinical Trial Inquiries
      • Manchester, United Kingdom, M20 4BX
        • Recruiting
        • USWM CT Investigational Site
        • Principal Investigator:
          • Fiona Thistlethwaite
        • Contact:
          • Clinical Trial Inquiries
      • Sutton, United Kingdom, SM2 5PT
        • Recruiting
        • The Royal Marsden NHS Foundation Trust
        • Principal Investigator:
          • Andrew Furness
        • Contact:
          • Clinical Trial Inquiries
  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University School of Medicine
        • Principal Investigator:
          • Melinda Yushak
        • Contact:
          • Clinical Trials Call Center
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • ADP Investigational Site
        • Principal Investigator:
          • Aaron Rapoport
        • Contact:
          • Clinical Trial Inquiries
      • Bethesda, Maryland, United States, 20892
        • Completed
        • National Cancer Institute - Center for Cancer Research
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Principal Investigator:
          • Rashmi Chugh
        • Contact:
          • Clinical Trial Inquiries
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine in St. Louis
        • Principal Investigator:
          • Brian Van Tine
        • Contact:
          • Clinical Trial Inquiries
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center - New York
        • Principal Investigator:
          • Sandra P D'Angelo
        • Contact:
          • MSKCC Clinical Trials Office
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center
        • Principal Investigator:
          • Richard Riedel
        • Contact:
          • Clinical Trial Inquiries
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health and Science University
        • Principal Investigator:
          • Lara Davis
        • Contact:
          • Clinical Trial Inquiries
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania
        • Principal Investigator:
          • Edward A Stadtmauer
        • Contact:
          • Clinical Trial Inquiries
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center
        • Principal Investigator:
          • Melissa Burgess
        • Contact:
          • Clinical Trial Inquiries
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • University of Texas Southwestern Medical Center
        • Principal Investigator:
          • John Samuel
        • Contact:
          • Clinical Trial Inquiries
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas MD Anderson Cancer Center
        • Principal Investigator:
          • Dejka Araujo
        • Contact:
          • Clinical Trial Inquiries
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Froedtert Hospital
        • Principal Investigator:
          • John A Charlson
        • Contact:
          • Clinical Trial Inquiries

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participants receiving ADP adoptive cell therapy
Biological: ADP 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with Vesicular Stomatitis Virus G protein (VSV-G) Deoxyribonucleic acid (DNA) copies in peripheral blood samples
Time Frame: 15 years
Peripheral blood samples will be collected for the assessment of VSV-G DNA copies.
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
Peripheral blood samples will be collected for the assessment of WPRE or Psi DNA.
15 years
Number of participants with integrated vector sequences and vector integration patterns identified in peripheral blood samples
Time Frame: 15 years
Peripheral blood samples will be collected for the assessment of Integrated vector sequences and vector integration patterns (e.g., polyclonal, oligoclonal, or monoclonal).
15 years
Number of deaths
Time Frame: 15 years
Number of deaths will be summarized.
15 years
Time to death
Time Frame: 15 years
Time to death will be summarized.
15 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

USWM CT, LLC

Investigators

  • Study Director: Michael Nathenson, MD, USWM CT, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 9, 2018

Primary Completion (Estimated)

April 1, 2032

Study Completion (Estimated)

April 1, 2032

Study Registration Dates

First Submitted

January 2, 2018

First Submitted That Met QC Criteria

January 2, 2018

First Posted (Actual)

January 5, 2018

Study Record Updates

Last Update Posted (Actual)

March 3, 2026

Last Update Submitted That Met QC Criteria

February 27, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 208750
  • ADP-0000-002 (Other Identifier: Adaptimmune Therapeutics)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD for this study will be made available via the Clinical Study Data Request site.

IPD Sharing Time Frame

IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.

IPD Sharing Access Criteria

Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neoplasms

Clinical Trials on ADP adoptive cell therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hong Kong

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe