CRISPR-Edited Allogeneic Anti-BCMA CAR-T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma
CaMMouflage
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)
1 other identifier
interventional
50
1 country
16
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Feb 2023
Longer than P75 for phase_1
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2022
CompletedStudy Start
First participant enrolled
February 6, 2023
CompletedFirst Posted
Study publicly available on registry
February 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
September 25, 2025
August 1, 2025
4.8 years
December 19, 2022
September 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
(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.
28 days
(Part B) Overall Response Rate (ORR)
The ORR will be evaluated by International Myeloma Working Group (IMWG) criteria.
12 Months
Study Arms (1)
CB-011
EXPERIMENTAL* 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 allogeneic CAR T cell therapy targeting BCMA Cyclophosphamide Chemotherapy for lymphodepletion Fludarabine Chemotherapy for lymphodepletion
Eligibility Criteria
You may qualify if:
- Documented diagnosis of relapsed/refractory multiple myeloma (MM) with measurable disease (according to IMWG diagnostic criteria.)
- 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.
- Eastern Cooperative Oncology Group performance status grade of 0 or 1.
- Adequate hematologic, renal, hepatic, pulmonary, and cardiac function.
You may not qualify if:
- Prior treatment with CAR-T cell therapy directed at any target.
- Autologous stem cell transplant within the last 6 weeks before lymphodepletion.
- Allogeneic stem cell transplant within 6 months before lymphodepletion.
- Known active or prior history of CNS involvement.
- Stroke or seizure within 6 months of signing ICF.
- Seropositive for or history of human immunodeficiency virus.
- Vaccinated with live, attenuated vaccine within 4 weeks prior to lymphodepletion.
- Hepatitis B infection.
- Hepatitis C infection.
- Known life-threatening allergies, hypersensitivity, or intolerance to CB-011 or its excipients.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
CU Anschutz Medical Campus, Anshutz Cancer Pavillion
Aurora, Colorado, 80045, United States
Sylvester Comprehensive Cancer Center, University of Miami Hospital and Clinics
Miami, Florida, 33136, United States
University of Kentucky/ Markey Cancer Center
Lexington, Kentucky, 40536, United States
Hackensack Meridian John Theurer Cancer Center
Hackensack, New Jersey, 07601, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Levine Cancer Institute
Charlotte, North Carolina, 28204, United States
Duke University Health System (DUHS)
Durham, North Carolina, 27705, United States
Oncology Hematology Care, Inc
Cincinnati, Ohio, 45236, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Tennessee Oncology
Nashville, Tennessee, 37203, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, 84112, United States
Virginia Commonwealth University
Richmond, Virginia, 23235, United States
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2022
First Posted
February 10, 2023
Study Start
February 6, 2023
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
September 25, 2025
Record last verified: 2025-08