Long Term Follow-up Study for Subjects Administered CLBR001
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: Long Term Follow-Up.
- Who it may be relevant to
- Registry conditions: Long Term Follow-Up. 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 →
Official title
A Study to Evaluate the Long Term Safety of CLBR001, a Lentiviral Based Chimeric Antigen Receptor, in Subjects Previously Administered CLBR001
Overview
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.
Detailed description
In line with FDA guidance on Long Term Follow-Up (LTFU) after administration of human gene therapy products, any subject who receives CLBR001 on any Calibr treatment study will participate in LTFU on this study. Subjects will be enrolled following completion on the applicable treatment study and followed for 15 years post-CLBR001 administration in order to assess the long term safety of CLBR001.
Interventions
- Other 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.
Primary outcome measures
- Number of subjects with adverse events as assessed by CTCAE v5.0. [Time frame: To 15 years post-CLBR001 administration.]
- Number of subjects with replication competent lentivirus (RCL). [Time frame: To 15 years post-CLBR001 administration.]
Eligibility criteria
Inclusion criteria
- Subjects who received at least one CLBR001 cell dose.
Exclusion criteria
- None
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
- Other
Study locations
United States · 3 centers
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center — Indianapolis
- Virtual Research Group- Premier Research — Morrisville
- University of Virginia — Charlottesville
Identifiers
NCT: NCT06882317 · CBR-CLBR001-3002