Multiple Myeloma Clinical Trial

CRISPR-Edited Allogeneic Anti-BCMA CAR-T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma

Summary

This is a Phase 1 study to evaluate the safety of CB-011 (the study treatment), an allogeneic chimeric antigen receptor (CAR-T) cell therapy that targets the B cell maturation antigen (BCMA), to determine the best dose of CB-011, and to assess the effectiveness of CB-011 in treating multiple myeloma that has come back (relapsed) or that is no longer responding to other treatment (refractory).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Documented diagnosis of relapsed/refractory multiple myeloma (MM) with measurable disease (according to IMWG diagnostic criteria.)
Received at least 3 prior MM treatment lines of therapy which must include a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody as part of a prior line of therapy, either in monotherapy or in combination.
Eastern Cooperative Oncology Group performance status grade of 0 or 1.
Adequate hematologic, renal, hepatic, pulmonary, and cardiac function.

Exclusion Criteria:

Prior treatment with CAR-T cell therapy directed at any target.
Autologous stem cell transplant within the last 6 weeks before lymphodepletion.
Allogeneic stem cell transplant within 6 months before lymphodepletion.
Known active or prior history of CNS involvement.
Stroke or seizure within 6 months of signing ICF.
Seropositive for or history of human immunodeficiency virus.
Vaccinated with live, attenuated vaccine within 4 weeks prior to lymphodepletion.
Hepatitis B infection.
Hepatitis C infection.
Known life-threatening allergies, hypersensitivity, or intolerance to CB-011 or its excipients.

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

50

Study ID:

NCT05722418

Recruitment Status:

Recruiting

Sponsor:

Caribou Biosciences, Inc.

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There are 3 Locations for this study

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Icahn School of Medicine at Mount Sinai
New York New York, 10029, United States More Info
Adriana Rossi, MD
Contact
917-828-3905
[email protected]
Adriana Rossi, MD
Principal Investigator
Oncology Hematology Care, Inc
Cincinnati Ohio, 45236, United States More Info
Doug Hart
Contact
[email protected]
James Essell, MD
Principal Investigator
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States More Info
Jesus Berdeja, MD
Contact
844-482-4812
[email protected]
Jesus Berdeja, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

50

Study ID:

NCT05722418

Recruitment Status:

Recruiting

Sponsor:


Caribou Biosciences, Inc.

How clear is this clinincal trial information?

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