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

Description

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

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Study Overview

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Study Details

Study overview

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).

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)

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

Condition
Relapsed/Refractory Multiple Myeloma
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35294

Aurora

CU Anschutz Medical Campus, Anshutz Cancer Pavillion, Aurora, Colorado, United States, 80045

Miami

Sylvester Comprehensive Cancer Center, University of Miami Hospital and Clinics, Miami, Florida, United States, 33136

Lexington

University of Kentucky/ Markey Cancer Center, Lexington, Kentucky, United States, 40536

Boston

Massachusetts General, Boston, Massachusetts, United States, 220071

Hackensack

John Theurer Cancer Center at Hackensack UMC, Hackensack, New Jersey, United States, 07601

New York

Icahn School of Medicine at Mount Sinai, New York, New York, United States, 10029

New York

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10065

Charlotte

Levine Cancer Institute, Charlotte, North Carolina, United States, 28204

Durham

Duke University Health System (DUHS), Durham, North Carolina, United States, 27705

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Caribou Biosciences, Inc.,

Study Record Dates

2027-02