Long-term Follow-up of Subjects Treated With CAR T Cells
NCT ID: NCT05024175
Last Updated: 2025-10-01
Study Results
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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RECRUITING
45 participants
OBSERVATIONAL
2023-08-07
2039-08-01
Brief Summary
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Detailed Description
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No investigational treatment will be administered in this study.
The FDA (2020) recommends long-term follow up for subjects treated with gene therapy drug products to monitor for delayed adverse events (AEs), as well as durability of clinical response.
Therefore, after monitoring of subjects in the main studies has been completed (24 months after CAR T cells infusion, or \<24 months after CAR T cells infusion if subject terminated early due to disease progression or due to discontinuing corresponding main study for any reason), subjects will be asked to participate in a long-term follow-up study (LTFU).
Subjects will be followed for up to 15 years following their last CAR T cells infusion in the corresponding main study.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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CAR T cells
* Eligibility to participate on this study if enrolled on a DF/HCC IRB corresponding main study and received infusion of CAR T cells
* The research study procedures include evaluations and follow up visits: Timepoints of each evaluation and follow up visit- per protocol
* Medical History/Physical Exam
* Blood Test
* Assessment of Disease: CT (Computerized Tomography) scan or PET-CT (Positron Emission Tomography-Computerized Tomography) scans.
* Tumor biopsy.
* Data Collection
* Biobanking
Disease assessments
CT (Computerized Tomography) scan or PET-CT (Positron Emission Tomography-Computerized Tomography) scans as per protocol
Tumor Biopsy
Tumor Biopsy per protocol
Blood test
Blood Test per protocol
Interventions
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Disease assessments
CT (Computerized Tomography) scan or PET-CT (Positron Emission Tomography-Computerized Tomography) scans as per protocol
Tumor Biopsy
Tumor Biopsy per protocol
Blood test
Blood Test per protocol
Eligibility Criteria
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Inclusion Criteria
Subjects meeting the following criteria are eligible for study participation:
* Provision of voluntary written informed consent by subject
* CAR T cells were administered in DF/HCC IRB corresponding main study
Exclusion Criteria
\- Subject unable to comply with study requirements
18 Years
ALL
No
Sponsors
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Marcela V. Maus, M.D.,Ph.D.
OTHER
Responsible Party
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Marcela V. Maus, M.D.,Ph.D.
Sponsor Investigator
Principal Investigators
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Matthew J Frigault, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20-721
Identifier Type: -
Identifier Source: org_study_id
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