Long-term Follow-up of Subjects Treated With CAR T Cells
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Disease assessments, Tumor Biopsy, Blood test.
- Who it may be relevant to
- Registry conditions: Long Term Adverse Effects, CAR-T, Duty to Follow Up, Adult. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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).
Detailed 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 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.
Interventions
- Diagnostic test Disease assessments
CT (Computerized Tomography) scan or PET-CT (Positron Emission Tomography-Computerized Tomography) scans as per protocol - Procedure Tumor Biopsy
Tumor Biopsy per protocol - Diagnostic test Blood test
Blood Test per protocol
Primary outcome measures
- Overall Survival [Time frame: 1 month]
- Overall Survival [Time frame: 6 months]
- Overall Survival [Time frame: 12 months]
- Overall Survival [Time frame: 24 months]
- Progresison Free Survival [Time frame: 1 month]
- Progresison Free Survival [Time frame: 6 months]
- Progresison Free Survival [Time frame: 12 months]
- Progresison Free Survival [Time frame: 24 months]
- New incidence or exacerbation of a pre-existing neurologic disorder or prior rheumatologic or other autoimmune disorder [Time frame: Up to 15 Years]
- New incidence of a hematologic disorder [Time frame: up to 15 years]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Massachusetts General Hospital — Boston
Identifiers
NCT: NCT05024175 · 20-721