Long Term Follow-up Study for Subjects Administered CLBR001 | NCT06882317 | Trialant

Long Term Follow-up Study for Subjects Administered CLBR001 | NCT06882317 | Trialant

Arms/Interventions Module

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of subjects with adverse events as assessed by CTCAE v5.0.	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.	To 15 years post-CLBR001 administration.
Number of subjects with replication competent lentivirus (RCL).	To assess the long term safety of CLBR001 in subjects by evaluating the proportion of subjects with detectable RCL from CLBR001.	To 15 years post-CLBR001 administration.

Contacts/Locations Module