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

Last updated: April 9, 2025
Sponsor: Caribou Biosciences, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Lymphoproliferative Disorders

Bone Diseases

Bone Neoplasm

Treatment

CB-011

Clinical Study ID

NCT05722418
CB11A
  • Ages > 18
  • All Genders

Study 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

Inclusion

Inclusion Criteria:

  1. Documented diagnosis of relapsed/refractory multiple myeloma (MM) with measurabledisease (according to IMWG diagnostic criteria.)

  2. Received at least 3 prior MM treatment lines of therapy which must include aproteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38monoclonal antibody as part of a prior line of therapy, either in monotherapy or incombination.

  3. Eastern Cooperative Oncology Group performance status grade of 0 or 1.

  4. Adequate hematologic, renal, hepatic, pulmonary, and cardiac function.

Exclusion

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 itsexcipients.

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: CB-011
Phase: 1
Study Start date:
February 06, 2023
Estimated Completion Date:
February 28, 2027

Connect with a study center

  • University of Alabama at Birmingham

    Birmingham, Alabama 35294
    United States

    Active - Recruiting

  • CU Anschutz Medical Campus, Anshutz Cancer Pavillion

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Sylvester Comprehensive Cancer Center, University of Miami Hospital and Clinics

    Miami, Florida 33136
    United States

    Active - Recruiting

  • University of Kentucky/ Markey Cancer Center

    Lexington, Kentucky 40536
    United States

    Active - Recruiting

  • Massachusetts General

    Boston, Massachusetts 220071
    United States

    Site Not Available

  • Hackensack Meridian John Theurer Cancer Center

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

  • John Theurer Cancer Center at Hackensack UMC

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Active - Recruiting

  • Levine Cancer Institute

    Charlotte, North Carolina 28204
    United States

    Active - Recruiting

  • Duke University Health System (DUHS)

    Durham, North Carolina 27705
    United States

    Active - Recruiting

  • Oncology Hematology Care, Inc

    Cincinnati, Ohio 45236
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • University of Texas Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Active - Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Huntsman Cancer Institute (Univ of Utah)

    Salt Lake City, Utah 84112
    United States

    Site Not Available

  • Huntsman Cancer Institute, University of Utah

    Salt Lake City, Utah 84112
    United States

    Active - Recruiting

  • Virginia Commonwealth University

    Richmond, Virginia 23235
    United States

    Active - Recruiting

  • Froedtert and the Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.