Actively Recruiting
Long-term Follow-up of Subjects Treated With CAR T Cells
Led by Marcela V. Maus, M.D.,Ph.D. · Updated on 2026-03-16
45
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a long-term safety and efficacy follow-up study for adults who have previously received CAR T cell therapy in related Phase 1 clinical studies. The purpose is to monitor subjects for delayed side effects and to assess how long the clinical response lasts after treatment. This follow-up is recommended by the FDA to ensure ongoing observation after gene therapy drug products. No new treatments will be given during this study. Instead, participants will undergo regular evaluations including medical history updates, physical exams, blood tests, CT or PET-CT scans, tumor biopsies, and data collection. These assessments will be scheduled according to the study protocol. Subjects will be followed for up to 15 years after their last CAR T cell infusion from the initial studies. Participants will attend follow-up visits where researchers will perform various tests to monitor overall survival, progression-free survival, any new or worsening neurological or autoimmune disorders, hematologic disorders, and treatment-related adverse events. Persistence of CAR T cells will also be assessed through blood tests. The study will include biobanking of samples and long-term data collection to evaluate the durability and safety of the CAR T cell therapy.
CONDITIONS
Brief Title
Long-term Follow-up of Subjects Treated With CAR T Cells
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided voluntary written informed consent
- Received CAR T cells in the DF/HCC IRB corresponding main study
- Able to comply with study procedures and follow-up visits
- Enrollment up to the last visit of the corresponding main study
You will not qualify if you...
- Unable to comply with study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 15 years following last CAR T cells infusion
Participants who have previously received CAR T cells are followed to monitor long-term safety and efficacy, including assessments for adverse events and clinical outcomes.
Follow-up visits per protocol including medical history, physical exams, blood tests, imaging scans, and tumor biopsies
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
M
Matthew J Frigault, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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