NCT05024175

Long-term Follow-up of Subjects Treated With CAR T Cells

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 45 (estimated)
• Sponsor: Marcela V. Maus, M.D.,Ph.D. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

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.

Conditions

• Long Term Adverse Effects
• CAR-T
• Duty to Follow Up
• Adult
• Progression-Free Survival
• Disease-Free Survival
• Overall Survival

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-08-07
• Primary completion: 2038-08-01
• Completion: 2039-08-01
• First posted: 2021-08-27
• Last updated: 2026-03-16

Locations

1 site across 1 country: United States