Long Term Follow-up Study for Subjects Administered CLBR001
A Study to Evaluate the Long Term Safety of CLBR001, a Lentiviral Based Chimeric Antigen Receptor, in Subjects Previously Administered CLBR001
1 other identifier
observational
40
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2025
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2025
CompletedFirst Posted
Study publicly available on registry
March 18, 2025
CompletedStudy Start
First participant enrolled
August 28, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2044
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2044
April 8, 2026
April 1, 2026
18.4 years
March 12, 2025
April 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of subjects with adverse events as assessed by CTCAE v5.0.
To assess the long term safety of CLBR001 in subjects by evaluating the incidence, duration, and outcome of adverse events (including adverse events of special interest, CLBR001-related adverse events and serious adverse events), as assessed by CTCAE v5.0.
To 15 years post-CLBR001 administration.
Number of subjects with replication competent lentivirus (RCL).
To assess the long term safety of CLBR001 in subjects by evaluating the proportion of subjects with detectable RCL from CLBR001.
To 15 years post-CLBR001 administration.
Study Arms (1)
CLBR001 Treated Subjects
Subjects who received CLBR001 on any Calibr treatment study.
Interventions
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.
Eligibility Criteria
Subjects who received CLBR001.
You may qualify if:
- Subjects who received at least one CLBR001 cell dose.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202, United States
Virtual Research Group- Premier Research
Morrisville, North Carolina, 27560, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Biospecimen
Frozen serum leftover following protocol-required testing of PK and ADA may be retained for future research or analytical development involving the same or related therapies or therapeutic areas, or for other relevant health research. This additional testing may involve genetic testing.
Study Officials
- STUDY DIRECTOR
Chief Medical Officer
Calibr-Skaggs Institute for Innovative Medicines
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2025
First Posted
March 18, 2025
Study Start
August 28, 2025
Primary Completion (Estimated)
February 1, 2044
Study Completion (Estimated)
February 1, 2044
Last Updated
April 8, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share