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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
CB-011 allogeneic CAR T cell therapy targeting BCMA Cyclophosphamide Chemotherapy for lymphodepletion Fludarabine Chemotherapy for lymphodepletion
University of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITING(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.
Time frame: 28 days
(Part B) Overall Response Rate (ORR)
The ORR will be evaluated by International Myeloma Working Group (IMWG) criteria.
Time frame: 12 Months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
CU Anschutz Medical Campus, Anshutz Cancer Pavillion
Aurora, Colorado, United States
RECRUITINGSylvester Comprehensive Cancer Center, University of Miami Hospital and Clinics
Miami, Florida, United States
RECRUITINGUniversity of Kentucky/ Markey Cancer Center
Lexington, Kentucky, United States
RECRUITINGHackensack Meridian John Theurer Cancer Center
Hackensack, New Jersey, United States
RECRUITINGIcahn School of Medicine at Mount Sinai
New York, New York, United States
RECRUITINGMemorial Sloan Kettering Cancer Center
New York, New York, United States
RECRUITINGLevine Cancer Institute
Charlotte, North Carolina, United States
RECRUITINGDuke University Health System (DUHS)
Durham, North Carolina, United States
RECRUITINGOncology Hematology Care, Inc
Cincinnati, Ohio, United States
RECRUITING...and 6 more locations