CB-012 is an allogeneic chimeric antigen receptor (CAR-T) cell therapy that targets C-type lectin-like molecule-1 (CLL-1). This is a Phase 1 study to evaluate the safety, preliminary efficacy, and pharmacokinetics, of CB-012 (the study treatment) in adults with acute myeloid leukemia (AML) that has come back after prior treatment (relapsed) or did not respond or is no longer responding to other treatment (refractory). Participants must have received at least 1 but not more than 3 prior lines of treatment for AML .
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
CB-012 allogeneic CAR-T cell therapy targeting CLL-1 Cyclophosphamide and Fludarabine chemotherapy for lymphodepletion
The University of Alabama at Birmingham (UAB)
Birmingham, Alabama, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Moffitt Cancer Center
Tampa, Florida, United States
The Blood & Marrow Transplant Group of Georgia (BMTGA)
Atlanta, Georgia, United States
Weill Cornell Medical College
New York, New York, United States
Memorial Sloan Kettering Cancer Center (MSKCC)
New York, New York, United States
TriStar Bone Marrow Transplant, LLC
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
(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-012.
Time frame: 28 days
(Part B) Overall Response Rate (ORR)
The ORR will be evaluated by European Leukemia Net (ELN) criteria
Time frame: 12 months
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