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NCT05722418PHASE1Recruiting

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

Caribou Biosciences, Inc.

Start Date

2/6/2023

Completion Date

12/1/2027

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).

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 1. Documented diagnosis of relapsed/refractory multiple myeloma (MM) with measurable disease (according to IMWG diagnostic criteria.) 2. 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. 3. Eastern Cooperative Oncology Group performance status grade of 0 or 1. 4. Adequate hematologic, renal, hepatic, pulmonary, and cardiac function. Exclusion Criteria: 1. Prior treatment with CAR-T cell therapy directed at any target. 2. Autologous stem cell transplant within the last 6 weeks before lymphodepletion. 3. Allogeneic stem cell transplant within 6 months before lymphodepletion. 4. Known active or prior history of CNS involvement. 5. Stroke or seizure within 6 months of signing ICF. 6. Seropositive for or history of human immunodeficiency virus. 7. Vaccinated with live, attenuated vaccine within 4 weeks prior to lymphodepletion. 8. Hepatitis B infection. 9. Hepatitis C infection. 10. Known life-threatening allergies, hypersensitivity, or intolerance to CB-011 or its excipients.

Interventions

BIOLOGICAL

CB-011

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Conditions

Relapsed/Refractory Multiple Myeloma

Locations

University of Alabama at Birmingham

Birmingham, Alabama 35294

United States

CU Anschutz Medical Campus, Anshutz Cancer Pavillion

Aurora, Colorado 80045

United States

Sylvester Comprehensive Cancer Center, University of Miami Hospital and Clinics

Miami, Florida 33136

United States

University of Kentucky/ Markey Cancer Center

Lexington, Kentucky 40536

United States

Hackensack Meridian John Theurer Cancer Center

Hackensack, New Jersey 07601

United States

Icahn School of Medicine at Mount Sinai

New York, New York 10029

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

Levine Cancer Institute

Charlotte, North Carolina 28204

United States

Duke University Health System (DUHS)

Durham, North Carolina 27705

United States

Oncology Hematology Care, Inc

Cincinnati, Ohio 45236

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

Tennessee Oncology

Nashville, Tennessee 37203

United States

University of Texas Southwestern Medical Center

Dallas, Texas 75390

United States

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah 84112

United States

Virginia Commonwealth University

Richmond, Virginia 23235

United States

Froedtert and the Medical College of Wisconsin

Milwaukee, Wisconsin 53226

United States