This is a Phase 1/1b dose-finding study of FT516 as monotherapy in acute myeloid leukemia (AML) and in combination with CD20 directed monoclonal antibodies in B-cell lymphoma. The study includes three stages: dose escalation, safety confirmation, and dose expansion.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
Experimental Interventional Therapy
Monoclonal Antibody
Monoclonal Antibody
Mayo Clinic
Phoenix, Arizona, United States
UC San Diego
San Diego, California, United States
University of Colorado, Denver
Denver, Colorado, United States
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, United States
The incidence of subjects with Dose Limiting Toxicities within each dose level cohort.
Time frame: Day 29
Incidence, nature, and severity of AEs, of FT516 as monotherapy in r/r AML and in combination with rituximab or obinutuzumab in r/r B-cell lymphoma.
Time frame: Up to 5 years
Investigator-assessed anti-tumor activity of FT516 as monotherapy in r/r AML and in combination with rituximab or obinutuzumab in r/r B-cell lymphoma.
Time frame: Cycle 2 Day 29
FT516 pharmacokinetic data
Percentage of donor DNA measured at each timepoint
Time frame: Cycle 1 and Cycle 2 Study Days: 1, 2, 4, 8, 11, 15, 18, 22, 29, and Cycle 2 Day 43 and Cycle 2 Day 57.
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Conditioning agent
Conditioning agent
Biologic response modifier
Conditioning agent
UT Southwestern
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Swedish Cancer Institute
Seattle, Washington, United States