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

Launched by CALIBR, A DIVISION OF SCRIPPS RESEARCH · Jul 22, 2020

Keywords

ClinConnect Summary

This is a long-term follow-up study for people who were treated with CLBR001, a CAR-T cell therapy for B-cell cancers (such as DLBCL, follicular lymphoma, CLL, mantle cell lymphoma, Burkitt lymphoma, Waldenstrom, and related diseases). The study will watch participants for up to 15 years after their CLBR001 infusion to learn about long-term safety, immune responses, and how well the cancer is doing over time. No new treatment is given in this study; instead, researchers will monitor health outcomes and collect data about any new adverse events, serious events, infections, or new cancers, as well as how well the cancer remains controlled.

Who may be eligible: adults aged 18 or older who already received at least one dose of CLBR001 and either completed or left the prior protocol, and who are willing to attend regular study visits and sign consent. There are no specific exclusion criteria listed. The plan is to enroll up to about 36 participants and to conduct visits at several major centers across the United States, including City of Hope, UC San Diego, University of Chicago, University of Minnesota, Weill Cornell/New York-Presbyterian, Wake Forest, and Sarah Cannon centers. Participants may have blood tests and possibly other samples to measure CAR-T cell levels, immune antibodies against the therapy, and check for any safety concerns or new cancers, with outcomes focused on long-term safety, overall cancer response, progression-free survival, and whether stem cell transplant occurs. The study is led by Calibr, a division of Scripps Research, and is regulated by the FDA.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • There are no specific exclusion criteria for this study