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RecruitingInterventionalPhase 1

A Phase 1, Multicenter, Open-Label Study of CB-011, a CRISPR-Edited Allogeneic Anti-BCMA CAR-T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma (CaMMouflage Trial)

NCT ID: NCT05722418Sponsor: Caribou Biosciences, Inc.Last updated: 2025-09-25

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).

Arms & interventions

  • BiologicalCB-011

    CB-011 allogeneic CAR T cell therapy targeting BCMA Cyclophosphamide Chemotherapy for lymphodepletion Fludarabine Chemotherapy for lymphodepletion

Outcome measures

Primary

  • (Part A) Number of patients with dose limiting toxicities (DLT)

    Number of patients with DLTs during the 28 days following the first administration of CB-011.

    Time frame: 28 days

  • (Part B) Overall Response Rate (ORR)

    The ORR will be evaluated by International Myeloma Working Group (IMWG) criteria.

    Time frame: 12 Months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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.

Study locations (16)

University of Alabama at Birmingham

Birmingham, Alabama, 35294

Recruiting
Luciano Costa, MD · Contact

CU Anschutz Medical Campus, Anshutz Cancer Pavillion

Aurora, Colorado, 80045

Recruiting
Daniel Sherbenou, MD, PhD · Principal Investigator

Sylvester Comprehensive Cancer Center, University of Miami Hospital and Clinics

Miami, Florida, 33136

Recruiting
Jay Spiegel, MD · Contact
Jay Spiegel, MD · Principal Investigator

University of Kentucky/ Markey Cancer Center

Lexington, Kentucky, 40536

Recruiting
Ashley Walton-Robbins · Contact
Gregory Monohan, MD · Principal Investigator

Hackensack Meridian John Theurer Cancer Center

Hackensack, New Jersey, 07601

Recruiting
Oncology Clinical Research Referral Office · Contact
David Siegal, MD · Principal Investigator

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

Recruiting
Adriana Rossi, MD · Contact
Adriana Rossi, MD · Principal Investigator

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Recruiting
Sham Mailankody, MBBS · Contact
Sham Mailankody, MBBS · Principal Investigator

Levine Cancer Institute

Charlotte, North Carolina, 28204

Recruiting
Kelly Bumgarner · Contact
Manisha Bhutani, MD · Principal Investigator

Duke University Health System (DUHS)

Durham, North Carolina, 27705

Recruiting
Matthew Fisher · Contact
Cristina Gasparetto, MD · Principal Investigator

Oncology Hematology Care, Inc

Cincinnati, Ohio, 45236

Recruiting
Doug Hart · Contact
James Essell, MD · Principal Investigator

Cleveland Clinic

Cleveland, Ohio, 44195

Recruiting
Faiz Anwer, MD · Principal Investigator

Tennessee Oncology

Nashville, Tennessee, 37203

Recruiting
Jesus Berdeja, MD · Contact
Taylor Peach · Contact
Jesus Berdeja, MD · Principal Investigator

University of Texas Southwestern Medical Center

Dallas, Texas, 75390

Recruiting
Marcella Aguilar · Contact
Larry Anderson, MD · Principal Investigator

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, 84112

Recruiting
Collind Boyington · Contact
Douglas Sborov, MD · Principal Investigator

Virginia Commonwealth University

Richmond, Virginia, 23235

Recruiting
Johanna Biamonte · Contact
William Clark, MD · Principal Investigator

Froedtert and the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

Recruiting
Danielle King · Contact
Binod Dhakal, MD · Principal Investigator