Long-term follow-up for patients treated with CAR T cells
Long-term Follow-up of Subjects Treated With CAR T Cells
This study looks at how well CAR T cell therapy works and its long-term safety for patients up to 15 years after their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Drugs / interventions | CAR T |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05024175 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on the long-term safety and efficacy of patients who have received CAR T cell therapy. It involves monitoring subjects for up to 15 years after their last CAR T cell infusion to assess any delayed adverse effects and the durability of their clinical response. Participants will undergo disease assessments, tumor biopsies, and blood tests as part of the follow-up process. The study aims to gather important data that aligns with FDA recommendations for long-term follow-up in gene therapy.
Who should consider this trial
Good fit: Ideal candidates are adults who have previously received CAR T cell therapy in the corresponding main studies.
Not a fit: Patients who are unable to comply with study requirements or have not received CAR T cells in the specified main studies will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the long-term effects and efficacy of CAR T cell therapy, improving patient management and safety.
How similar studies have performed: Other studies have successfully monitored long-term outcomes of CAR T cell therapy, indicating the importance of such follow-up assessments.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Matthew J Frigault, MD — Massachusetts General Hospital
- Study coordinator: Matthew J Frigault, MD
- Email: mfrigault@mgb.org
- Phone: 617-643-6175
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.