Long-term Follow-up Study for Patients Treated With CLBR001 CAR-T

This study is designed as a long-term follow-up study of participants who have receive genetically modified autologous CLBR001 CAR-T cells

All patients who received at least one CLBR001 cell dose and have either discontinued early or completed the core treatment protocol or any protocol such as a managed access protocol as applicable.
Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol

Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04488354.

Fred Hutch/University of Washington/Seattle Children's Cancer Consortium

Status: Approved

Name Not Available

Patients will be enrolled following either the completion or early

termination/discontinuation from Study NCT04450069 or any protocol in which patients were

administered CLBR001. Patients will begin the long-term follow-up period regardless of

whether they responded to treatment or progressed on treatment. Patients will be followed

for up to 15 years post CLBR001 infusion and will continue to be monitored for safety,

immunogenicity, and efficacy.

Trial PhasePhase I

Trial TypeNot provided by clinicaltrials.gov

Lead OrganizationCalibr, a division of Scripps Research

Description