This is a Phase I dose-finding study of FT576 as monotherapy and in combination with the monoclonal antibody daratumumab in multiple myeloma (MM). The study will consist of a dose-escalation stage and an expansion stage.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Experimental Interventional Therapy: FT576 comprises allogeneic natural killer (NK) cells, derived from a clonal, CD38-knockout, human-induced pluripotent stem cell line (iPSC) that expresses anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR), high-affinity, non-cleavable CD16 (hnCD16), and IL-15/IL-15 receptor fusion protein (IL-15RF).
Conditioning Agent
Conditioning Agent
University of Alabama at Birmingham
Birmingham, Alabama, United States
City of Hope
Duarte, California, United States
Scri-Cbci
Denver, Colorado, United States
Incidence and nature of DLTs within each dose-escalation cohort to determine the MTD or MAD
Time frame: Cycle 1 Day -5 to Day 29 for Regimen A and A1; Cycle 1 Day -11 to Day 29 (each cycle is 40 days) for Regimen B and B1
Determine the RP2D which will be based on the overall safety and anti-tumor activity among the dose escalation and dose expansion cohorts
Time frame: From FPI to LPI's end of Cycle 1 study treatment (End of cycle is Day 29 from Day 1 FT576 infusion)
Incidence, nature, and severity of adverse events
Time frame: Cycle 1 Day -5 to Day 29 for Regimen A and A1; Cycle 1 Day -11 to Day 29 (each cycle is 40 days) for Regimen B and B1
Objective response rate (ORR)
Proportion of subjects with a best overall response of sCR, CR, VGPR, or PR, as determined by the investigator according to standard IMWG response criteria
Time frame: From baseline tumor assessment up to approximately 2 years after last dose of FT576
Duration of response (DOR)
Duration from the first occurrence of a documented objective response until the time of disease progression or relapse, or death due to progressive disease, as determined by the investigator according to standard IMWG response criteria
Time frame: Up to 15 years
Progression-free survival (PFS)
Time from first dose of study treatment to disease progression or relapse, or to the day of death from any cause, as determined by the investigator according to standard IMWG response criteria
Time frame: Up to 15 years
Relapse-free survival (RFS) from complete response (CR)
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Anti-CD38 Monoclonal Antibody
Conditioning Agent
Medical Oncology Hematology Consultants
Newark, Delaware, United States
Indiana University
Indianapolis, Indiana, United States
University of Minnesota
Saint Paul, Minnesota, United States
Washington University
St Louis, Missouri, United States
Roswell Park
Buffalo, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Oncology Hematology Care, Inc
Cincinnati, Ohio, United States
...and 4 more locations
Duration from the start of sCR or CR until the time of relapse from sCR or CR, as determined by the investigator according to standard IMWG response criteria
Time frame: Up to 15 years
Overall survival (OS)
Time from first dose of study treatment to death from any cause
Time frame: Up to 15 years
Pharmacokinetics (PK) of FT576
Concentration of FT576 in peripheral blood following FT576 administration
Time frame: From Baseline to PTFU visit of last cycle on the study treatment (End of cycle is Day 29 from Day 1 FT576 infusion of this cycle)