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

Phase 1

Recruiting

• Conditions: Neoplasms

• Registration Number: NCT03391778
• Lead Sponsor: Adaptimmune

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.

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 Timeline

• Study First Submitted: 2018-01-02
• Study First Submitted QC: 2018-01-02
• Study First Posted: 2018-01-05
• Study Start: 2018-04-09
• Status Verified: 2024-02
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03
• Primary Completion: 2032-04-01
• Study Completion: 2032-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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• Participants who have completed ADP sponsored or supported interventional study or have withdrawn from it.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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of participants with Woodchuck hepatitis virus post-transcriptional regulatory element (WPRE) or Psi DNA copies in peripheral blood samples.	15 years	Peripheral blood samples will be collected for the assessment of WPRE or Psi DNA.
Time to death	15 years	Time to death will be summarized.
Number of participants with Vesicular Stomatitis Virus G protein (VSV-G) Deoxyribonucleic acid (DNA) copies in peripheral blood samples	15 years	Peripheral blood samples will be collected for the assessment of VSV-G DNA copies.
Number of deaths	15 years	Number of deaths will be summarized.
Number of participants with integrated vector sequences and vector integration patterns identified in peripheral blood samples	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).

Trial Locations

Locations (23)

Emory University School of Medicine; 🇺🇸 Atlanta, Georgia, United States

ADP Investigational Site; 🇬🇧 Manchester, United Kingdom

National Cancer Institute - Center for Cancer Research; 🇺🇸 Bethesda, Maryland, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Washington University School of Medicine in St. Louis; 🇺🇸 Saint Louis, Missouri, United States

Memorial Sloan Kettering Cancer Center - New York; 🇺🇸 New York, New York, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

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