Marcela V. Maus, M.D.,Ph.D.
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 (HCC# 22-175), NCT06026319 (HCC# 23-474) and NCT NCT07388277 (MGB# 2025P003179.
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…
Inclusion Criteria: Subjects will be asked to participate leading up to the last HCC or MGB 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 HCC IRB or MGB 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
CT (Computerized Tomography) scan or PET-CT (Positron Emission Tomography-Computerized Tomography) scans as per protocol
Tumor Biopsy per protocol
Blood Test per protocol
Arctuva estimate
Verify or correct the compensation shown for this listing.