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)
Status: Recruiting
Location: See all (16) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
Colorado
CU Anschutz Medical Campus, Anshutz Cancer Pavillion
RECRUITING
Aurora
Florida
Sylvester Comprehensive Cancer Center, University of Miami Hospital and Clinics
RECRUITING
Miami
Kentucky
University of Kentucky/ Markey Cancer Center
RECRUITING
Lexington
North Carolina
Levine Cancer Institute
RECRUITING
Charlotte
Duke University Health System (DUHS)
RECRUITING
Durham
New Jersey
Hackensack Meridian John Theurer Cancer Center
RECRUITING
Hackensack
New York
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Ohio
Oncology Hematology Care, Inc
RECRUITING
Cincinnati
Cleveland Clinic
RECRUITING
Cleveland
Tennessee
Tennessee Oncology
RECRUITING
Nashville
Texas
University of Texas Southwestern Medical Center
RECRUITING
Dallas
Utah
Huntsman Cancer Institute, University of Utah
RECRUITING
Salt Lake City
Virginia
Virginia Commonwealth University
RECRUITING
Richmond
Wisconsin
Froedtert and the Medical College of Wisconsin
RECRUITING
Milwaukee
Contact Information
Primary
Caribou Biosciences
clinicaltrials@cariboubio.com
510-982-6030
Time Frame
Start Date:2023-02-06
Estimated Completion Date:2027-12
Participants
Target number of participants:50
Treatments
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