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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06882317

Enrollment

Registered

2025-03-18

Start date

2025-08-28

Completion date

2044-02-01

Last updated

2026-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Long Term Follow-Up

Keywords

Long Term Follow-Up (LTFU), CLBR001, Autologous Cell Therapy, Switchable CAR-T Cell, Cell and Gene Therapy

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.

Interventions

OTHERLong 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.

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Subjects who received at least one CLBR001 cell dose.

Exclusion criteria

* None

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Contacts

STUDY_DIRECTORChief Medical Officer

Calibr-Skaggs Institute for Innovative Medicines

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 9, 2026