RecruitingPhase 1NCT05722418

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

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)


Sponsor

Caribou Biosciences, Inc.

Enrollment

50 participants

Start Date

Feb 6, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an off-the-shelf (allogeneic) CAR-T cell therapy — immune cells engineered using CRISPR gene-editing to target a protein called BCMA found on myeloma cells — in patients with multiple myeloma that has relapsed (come back) or is refractory (not responding) to multiple prior treatments. Unlike standard CAR-T, these cells come from a donor rather than the patient. **You may be eligible if...** - You have confirmed multiple myeloma that has relapsed or is refractory - You have already tried at least 3 prior treatment regimens, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody - Your general health is reasonably good (ECOG 0-1) - Your organ function (blood, liver, kidneys, heart, lungs) is adequate **You may NOT be eligible if...** - You have previously received CAR-T cell therapy for any target - You had an autologous stem cell transplant less than 6 weeks ago, or an allogeneic transplant less than 6 months ago - You have HIV, active hepatitis B or C, or known active brain involvement by myeloma - You have had a seizure or stroke in the past 6 months - You have received a live vaccine within 4 weeks before starting treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALCB-011

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


Locations(16)

University of Alabama at Birmingham

Birmingham, Alabama, United States

CU Anschutz Medical Campus, Anshutz Cancer Pavillion

Aurora, Colorado, United States

Sylvester Comprehensive Cancer Center, University of Miami Hospital and Clinics

Miami, Florida, United States

University of Kentucky/ Markey Cancer Center

Lexington, Kentucky, United States

Hackensack Meridian John Theurer Cancer Center

Hackensack, New Jersey, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Levine Cancer Institute

Charlotte, North Carolina, United States

Duke University Health System (DUHS)

Durham, North Carolina, United States

Oncology Hematology Care, Inc

Cincinnati, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

Tennessee Oncology

Nashville, Tennessee, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Froedtert and the Medical College of Wisconsin

Milwaukee, Wisconsin, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05722418


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