NCT06882317

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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Calibr, a division of Scripps Research · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Long Term Follow-Up

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-08-28
• Primary completion: 2044-02-01
• Completion: 2044-02-01
• First posted: 2025-03-18
• Last updated: 2026-04-08

Locations

3 sites across 1 country: United States