Long Term Follow-up Study for Subjects Administered CLBR001

Not yet recruiting

• Conditions: Long Term Follow-Up

• Registration Number: NCT06882317
• Lead Sponsor: Calibr, a division of Scripps Research

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.

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.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-12
• Study First Submitted QC: 2025-03-12
• Last Update Submitted: 2025-03-12
• Study First Posted: 2025-03-18
• Last Update Posted: 2025-03-18
• Study Start: 2025-05
• Primary Completion: 2044-02
• Study Completion: 2044-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Subjects who received at least one CLBR001 cell dose.

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of subjects with adverse events as assessed by CTCAE v5.0.	To 15 years post-CLBR001 administration.	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.
Number of subjects with replication competent lentivirus (RCL).	To 15 years post-CLBR001 administration.	To assess the long term safety of CLBR001 in subjects by evaluating the proportion of subjects with detectable RCL from CLBR001.