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

Trial Status: Active

This study is designed as a long-term follow-up study of participants who have receive genetically modified autologous CLBR001 CAR-T cells in all clinical trials including NCT04450069, A Phase 1, Open-label, Dose Escalating Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Activity of the Combination of CLBR001 and SWI019 in Patients With Relapsed / Refractory B-cell Malignancies.

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

California

Duarte
City of Hope Comprehensive Cancer Center
Status: ACTIVE
San Diego
University of California San Diego
Status: ACTIVE

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: ACTIVE

North Carolina

Winston-Salem
Wake Forest University Health Sciences
Status: APPROVED

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 Phase Phase I

Trial Type Treatment

Lead Organization
Calibr, a division of Scripps Research

  • Primary ID CBR-sCAR19-3002
  • Secondary IDs NCI-2020-08203
  • Clinicaltrials.gov ID NCT04488354