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Long Term Follow-up Study for Subjects Administered CLBR001
Sponsor: Calibr, a division of Scripps Research
Summary
The goal of this Long Term Follow-Up observational study is to monitor subjects who have received CLBR001, a lentiviral vector based chimeric antigen receptor, for delayed adverse events that may be associated with human gene therapies. Participants will be followed for 15 years post-gene therapy administration date for safety and efficacy.
Official title: A Study to Evaluate the Long Term Safety of CLBR001, a Lentiviral Based Chimeric Antigen Receptor, in Subjects Previously Administered CLBR001
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
40
Start Date
2025-08-28
Completion Date
2044-02
Last Updated
2026-04-08
Healthy Volunteers
No
Conditions
Interventions
Long Term Follow-Up
No intervention is administered on this study. Subjects who have received CLBR001 autologous CAR-T cells in a primary Calibr treatment trial will be followed long term in line with FDA guidance.
Locations (3)
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States
Virtual Research Group- Premier Research
Morrisville, North Carolina, United States
University of Virginia
Charlottesville, Virginia, United States