Long-term Follow-up of Subjects Treated With CAR T Cells
Marcela V. Maus, M.D.,Ph.D.
Summary
This is a single site, non-randomized, open-label, long-term safety and efficacy follow-up study for Phase 1 studies that evaluate the safety and efficacy of CAR T cells: NCT05660369 (DF/HCC# 22-175) and NCT06026319 (DF/HCC# 23-474).
Description
This is a long-term safety and efficacy follow-up study for subjects who have been treated with CAR T cells in corresponding Phase I main studies that evaluated the safety and efficacy of CAR T cells in subjects. 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 month…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Subjects will be asked to participate leading up to the last DF/HCC corresponding main study visit. 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: Subjects meeting the following criterion are to be excluded from study participation: \- Subject unable to comply with study requirements
Interventions
- Diagnostic TestDisease assessments
CT (Computerized Tomography) scan or PET-CT (Positron Emission Tomography-Computerized Tomography) scans as per protocol
- ProcedureTumor Biopsy
Tumor Biopsy per protocol
- Diagnostic TestBlood test
Blood Test per protocol
Location
- Massachusetts General HospitalBoston, Massachusetts