Long Term Follow-up Study for Subjects Administered CLBR001

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.

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Key information

Conditions

Long Term Follow-Up

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, Indiana, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects who received at least one CLBR001 cell dose.

Exclusion criteria

None

Treatment and study plan

Long Term Follow-Up

Other

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 outcomes

Number of subjects with adverse events as assessed by CTCAE v5.0.

Time frame: 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).

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Calibr, a division of Scripps Research

Other

Registry information

Official study title

A Study to Evaluate the Long Term Safety of CLBR001, a Lentiviral Based Chimeric Antigen Receptor, in Subjects Previously Administered CLBR001

Important dates

Study start: 2025
Primary completion: 2044
Study completion: 2044
First posted: Mar 18, 2025
Registry last updated: Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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