Long Term Follow-up Study for Subjects Administered CLBR001

Calibr, a division of Scripps Research

Status: Invitation-only

Conditions: Long Term Follow-Up

Treatments: Other: Long Term Follow-Up

Study type: Observational

Funder types: Other

Identifiers

NCT06882317

CBR-CLBR001-3002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects who received at least one CLBR001 cell dose.

Exclusion criteria

• None

Trial design

40 participants in 1 patient group

CLBR001 Treated Subjects

Description:

Subjects who received CLBR001 on any Calibr treatment study.

Treatment:

Other: Long Term Follow-Up