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

Recruiting now · Phase 1

Conditions studied: Relapsed/Refractory Multiple Myeloma

In brief

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).

Key facts

Study ID

NCT05722418

Run by

Caribou Biosciences, Inc.

People needed

50

Starts

2023-02-06

Expected to finish

2027-12-01

Last updated by the study team

2025-09-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
• CU Anschutz Medical Campus, Anshutz Cancer Pavillion — Aurora, Colorado, United States (enrolling)
• Sylvester Comprehensive Cancer Center, University of Miami Hospital and Clinics — Miami, Florida, United States (enrolling)
• University of Kentucky/ Markey Cancer Center — Lexington, Kentucky, United States (enrolling)
• Hackensack Meridian John Theurer Cancer Center — Hackensack, New Jersey, United States (enrolling)
• Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• Levine Cancer Institute — Charlotte, North Carolina, United States (enrolling)
• Duke University Health System (DUHS) — Durham, North Carolina, United States (enrolling)
• Oncology Hematology Care, Inc — Cincinnati, Ohio, United States (enrolling)
• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• Tennessee Oncology — Nashville, Tennessee, United States (enrolling)
• University of Texas Southwestern Medical Center — Dallas, Texas, United States (enrolling)
• Huntsman Cancer Institute, University of Utah — Salt Lake City, Utah, United States (enrolling)
• Virginia Commonwealth University — Richmond, Virginia, United States (enrolling)
• Froedtert and the Medical College of Wisconsin — Milwaukee, Wisconsin, United States (enrolling)

Full record on ClinicalTrials.gov

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