Chronic Lymphocytic Leukemia Clinical Trial

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

Summary

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

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Full Description

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.

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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

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 1

Estimated Enrollment:

36

Study ID:

NCT04488354

Recruitment Status:

Enrolling by invitation

Sponsor:

Calibr, a division of Scripps Research

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There are 8 Locations for this study

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City of Hope National Medical Center
Duarte California, 91010, United States
University of California at San Diego
San Diego California, 92093, United States
University of Chicago
Chicago Illinois, 60637, United States
Masonic Cancer Center, University of Minnesota
Minneapolis Minnesota, 55455, United States
Weill Cornell Medical College - New York Presbyterian Hospital
New York New York, 10065, United States
Wake Forest Baptist Health
Winston-Salem North Carolina, 27157, United States
Sarah Cannon Research Institute - Tennessee Oncology
Nashville Tennessee, 37203, United States
Sarah Cannon Research Institute - Texas Transplant Institute
San Antonio Texas, 78229, United States

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 1

Estimated Enrollment:

36

Study ID:

NCT04488354

Recruitment Status:

Enrolling by invitation

Sponsor:


Calibr, a division of Scripps Research

How clear is this clinincal trial information?

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