Long Term Follow-up Study for Subjects Administered CLBR001

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Calibr, a division of Scripps Research
Study ID
NCT06882317
Status
Enrolling By Invitation

Conditions

  • Long Term Follow-Up

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Aug 28, 2025
Status verified
Apr 2026
Primary completion
Feb 29, 2044
Completion
Feb 29, 2044

Study Design

Enrollment
40 participants (estimated)

Arms

  • Arm: CLBR001 Treated Subjects
    Subjects who received CLBR001 on any Calibr treatment study.

Primary Outcome Measure

Number of subjects with adverse events as assessed by CTCAE v5.0. [ Time Frame: To 15 years post-CLBR001 administration. ]

Locations (3)

FacilityCityStateZIPSite coordinators
Indiana University Melvin and Bren Simon Comprehensive Cancer CenterIndianapolisIndiana46202-
Virtual Research Group- Premier ResearchMorrisvilleNorth Carolina27560-
University of VirginiaCharlottesvilleVirginia22908-

Find similar trials in Indianapolis, IN

By research site
Indiana University Melvin and Bren Simon Comprehensive Cancer Center· Indianapolis, INVirtual Research Group- Premier Research· Morrisville, NCUniversity of Virginia· Charlottesville, VA

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