🔎 Trials Near Me

Home › Multiple Myeloma › NCT05722418

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

RecruitingPhase 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)

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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.

About the study

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).

What is being tested

Sponsor: Caribou Biosciences, Inc. · Participants: 50 · Started: Feb 6, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT05722418

Locations in the U.S.

AlabamaUniversity of Alabama at Birmingham, Birmingham
ColoradoCU Anschutz Medical Campus, Anshutz Cancer Pavillion, Aurora
FloridaSylvester Comprehensive Cancer Center, University of Miami Hospital and Clinics, Miami
KentuckyUniversity of Kentucky/ Markey Cancer Center, Lexington
New JerseyHackensack Meridian John Theurer Cancer Center, Hackensack
New YorkIcahn School of Medicine at Mount Sinai, New York
Memorial Sloan Kettering Cancer Center, New York
North CarolinaLevine Cancer Institute, Charlotte
Duke University Health System (DUHS), Durham
OhioOncology Hematology Care, Inc, Cincinnati
Cleveland Clinic, Cleveland
TennesseeTennessee Oncology, Nashville
TexasUniversity of Texas Southwestern Medical Center, Dallas
UtahHuntsman Cancer Institute, University of Utah, Salt Lake City
VirginiaVirginia Commonwealth University, Richmond
WisconsinFroedtert and the Medical College of Wisconsin, Milwaukee

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.