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

NCT ID: NCT03391778

Last Updated: 2024-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-09

Study Completion Date

2032-04-01

Brief Summary

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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

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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.

Conditions

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Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Participants receiving ADP adoptive cell therapy

Group Type EXPERIMENTAL

ADP adoptive cell therapy

Intervention Type 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.

Interventions

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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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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* Participants who have completed ADP sponsored or supported interventional study or have withdrawn from it.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

ALL

Accepts Healthy Volunteers

No

Sponsors

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Adaptimmune

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adaptimmune

Role: STUDY_DIRECTOR

Adaptimmune

Locations

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Emory University School of Medicine

Atlanta, Georgia, United States

Site Status RECRUITING

ADP Investigational Site

Baltimore, Maryland, United States

Site Status RECRUITING

National Cancer Institute - Center for Cancer Research

Bethesda, Maryland, United States

Site Status COMPLETED

University of Michigan

Ann Arbor, Michigan, United States

Site Status RECRUITING

Washington University School of Medicine in St. Louis

St Louis, Missouri, United States

Site Status RECRUITING

Memorial Sloan Kettering Cancer Center - New York

New York, New York, United States

Site Status RECRUITING

Duke University Medical Center

Durham, North Carolina, United States

Site Status RECRUITING

Oregon Health and Science University

Portland, Oregon, United States

Site Status RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status RECRUITING

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Froedtert Hospital

Milwaukee, Wisconsin, United States

Site Status RECRUITING

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Site Status RECRUITING

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Site Status RECRUITING

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Site Status RECRUITING

Klinikum rechts der Isar der Technischen Universität München

Munich, Bavaria, Germany

Site Status RECRUITING

Uniklinik Köln

Cologne, North Rhine-Westphalia, Germany

Site Status RECRUITING

Fondazione IRCCS - Istituto Nazionale dei Tumori

Milan, Lombardy, Italy

Site Status RECRUITING

Antoni Van Leeuwenhoek Ziekenhuis

Amsterdam, , Netherlands

Site Status RECRUITING

Hospital Universitario Virgen del Rocío

Seville, , Spain

Site Status RECRUITING

University College London Hospitals NHS Foundation Trust

London, , United Kingdom

Site Status RECRUITING

ADP Investigational Site

Manchester, , United Kingdom

Site Status RECRUITING

The Royal Marsden NHS Foundation Trust

Sutton, , United Kingdom

Site Status RECRUITING

Countries

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United States Australia Canada Germany Italy Netherlands Spain United Kingdom

Central Contacts

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Adaptimmune Patient Enquiries Call Center

Role: CONTACT

215-825-9260

Facility Contacts

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US GSK Clinical Trials Call Center

Role: primary

215-825-9260

Adaptimmune Patient Enquiries

Role: primary

215-825-9260

Adaptimmune Patient Enquiries

Role: primary

215-825-9260

Adaptimmune Patient Enquiries

Role: primary

215-825-9260

Adaptimmune Patient Enquiries

Role: primary

215-825-9260

Adaptimmune Patient Enquiries

Role: primary

215-825-9260

Adaptimmune Patient Enquiries

Role: primary

215-825-9260

Adaptimmune Patient Enquiries

Role: primary

215-825-9260

Adaptimmune Patient Enquiries

Role: primary

215-825-9260

Adaptimmune Patient Enquiries

Role: primary

215-825-9260

Adaptimmune Patient Enquiries

Role: primary

215-825-9260

Adaptimmune Patient Enquiries

Role: primary

215-825-9260

Adaptimmune Patient Enquiries

Role: primary

215-825-9260

Adaptimmune Patient Enquiries

Role: primary

215-825-9260

Adaptimmune Patient Enquiries

Role: primary

215-825-9260

Adaptimmune Patient Enquiries

Role: primary

215-825-9260

Adaptimmune Patient Enquiries

Role: primary

215-825-9260

Adaptimmune Patient Enquiries

Role: primary

215-825-9260

Adaptimmune Patient Enquiries

Role: primary

215-825-9260

Adaptimmune Patient Enquiries

Role: primary

215-825-9260

Adaptimmune Patient Enquiries

Role: primary

215-825-9260

Adaptimmune Patient Enquiries

Role: primary

215-825-9260

Adaptimmune Patient Enquiries

Role: primary

215-825-9260

Other Identifiers

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ADP-0000-002

Identifier Type: OTHER

Identifier Source: secondary_id

208750

Identifier Type: -

Identifier Source: org_study_id

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