Recruiting
Phase 1

Anti-BCMA CAR-T

Sponsor:

Caribou Biosciences, Inc.

Code:

NCT05722418

Conditions

Relapsed/Refractory Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CB-011

Study Details

Brief 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).

Conditions

Relapsed/Refractory Multiple Myeloma

Study ID

NCT05722418

Start date

Feb 6, 2023

Status verified date

Aug, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CB-011

  • Part A Escalation with CB-011 in ascending doses using a traditional 3+3 design.
  • Part B Expansion. Up to 30 participants will be enrolled to receive CB-011 at the RDE/MTD and/or RP2D determined in Plan A

Interventions

CB-011

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

Primary outcome measure

  • (Part A) Number of patients with dose limiting toxicities (DLT) [ Time Frame: 28 days ]
  • (Part B) Overall Response Rate (ORR) [ Time Frame: 12 Months ]

Central Contacts and Locations

Central contacts

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

CU Anschutz Medical Campus, Anshutz Cancer Pavillion

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Principal Investigator:

Daniel Sherbenou, MD, PhD

Sylvester Comprehensive Cancer Center, University of Miami Hospital and Clinics

Recruiting

Miami, Florida, United States, 33136

Contacts

Principal Investigator:

Jay Spiegel, MD

University of Kentucky/ Markey Cancer Center

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Principal Investigator:

Gregory Monohan, MD

Hackensack Meridian John Theurer Cancer Center

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Oncology Clinical Research Referral Office

551-996-1777oncologyresearchreferral@hmhn.org

Principal Investigator:

David Siegal, MD

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Principal Investigator:

Adriana Rossi, MD

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Sham Mailankody, MBBS

646-608-2091cart@mskcc.org

Principal Investigator:

Sham Mailankody, MBBS

Levine Cancer Institute

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Principal Investigator:

Manisha Bhutani, MD

Duke University Health System (DUHS)

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Principal Investigator:

Cristina Gasparetto, MD

Oncology Hematology Care, Inc

Recruiting

Cincinnati, Ohio, United States, 45236

Contacts

Principal Investigator:

James Essell, MD

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Principal Investigator:

Faiz Anwer, MD

Tennessee Oncology

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Principal Investigator:

Jesus Berdeja, MD

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Principal Investigator:

Larry Anderson, MD

Huntsman Cancer Institute, University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Principal Investigator:

Douglas Sborov, MD

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23235

Contacts

Principal Investigator:

William Clark, MD

Froedtert and the Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Principal Investigator:

Binod Dhakal, MD

More Information

Sponsor

Caribou Biosciences, Inc.

Last update posted

Sep 25, 2025

Last verified

Aug, 2025

Keywords

  • CaMMouflage
  • Allogeneic
  • Multiple Myeloma
  • Relapse Refractory Multiple Myeloma
  • CAR-T Cells
  • BCMA
  • Cell Therapy
  • Cellular Immuno-therapy
  • CB11A
  • CB-011
  • CB-011A
  • CAR-T
  • Anti BCMA
  • ALLO CAR T

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Caribou Biosciences, Inc. on 2025-09-25.