This is a Phase I dose-finding study of FT538 as monotherapy in acute myeloid leukemia (AML) and in combination with monoclonal antibodies in multiple myeloma (MM). The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Experimental Interventional Therapy, Allogeneic Cell Therapy NK Cell
Lympho-conditioning Agent
Lympho-conditioning Agent
Colorado Blood Cancer Institute
Denver, Colorado, United States
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, United States
Washington University
St Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center
Incidence of dose-limiting toxicities (DLTs) within each dose level cohort
Time frame: Cycle 1, Up to Day 29
Nature of dose-limiting toxicities within each dose level cohort
Time frame: Cycle 1, Up to Day 29
Incidence, nature, and severity of adverse events (AEs) of FT538 as monotherapy in r/r AML and in combination with daratumumab or elotuzumab in r/r multiple myeloma
Time frame: Up to 5 years
Objective response rate (ORR) of FT538 as monotherapy in r/r AML and in combination with daratumumab or elotuzumab in r/r MM
Proportion of subjects who achieve a CR, CRMRD-, CRi, MLFS, or PR, as determined by the investigator according to 2017 ELN criteria for AML, and the proportion of subjects with a best overall response of sCR, CR, VGPR, or PR, as determined by the investigator according to standard IMWG for MM response criteria
Time frame: From baseline tumor assessment up to approximately 2 years after last dose of FT538
Duration of response (DOR) of FT538 in combination with daratumumab or elotuzumab in r/r MM
Defined as the 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) of FT538 in combination with daratumumab or elotuzumab in r/r MM
Defined as the 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
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Monoclonal Antibody, CD38, Anti-CD38
Monoclonal Antibody
New York, New York, United States
Sarah Cannon Research Institute at Tennessee Oncology
Nashville, Tennessee, United States
St. David's South Austin Medical Center
Austin, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Texas Transplant Institute
San Antonio, Texas, United States
Relapse-free survival (RFS) of FT538 as monotherapy in r/r AML and in combination with daratumumab or elotuzumab in r/r MM
Defined as the time from initial CR (including CRMRD-, CR, and CRi) to hematologic relapse or death due to any cause, as determined by the investigator according to 2017 ELN criteria for AML, and defined as the 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 for MM
Time frame: Up to 15 years
Event-free survival (EFS) of FT538 as monotherapy in r/r AML
defined as the time from first dose of lympho-conditioning to the date of PD, or relapse from CR or CRi, or death from any cause, according to 2017 ELN criteria
Time frame: Up to 15 years
Overall survival (OS) of FT538 as monotherapy in r/r AML and in combination with daratumumab or elotuzumab in r/r MM
defined as the time from first dose of lympho-conditioning to death from any cause
Time frame: Up to 15 years
Time-to-best response of FT538 as monotherapy in r/r AML
defined as the time from first dose of lympho-conditioning to best response
Time frame: Up to 15 years
Determination of the pharmacokinetics (PK) of FT538 cells in peripheral blood
The PK of FT538 in peripheral blood will be reported as the relative percentage of product (FT538) DNA versus patient DNA (% chimerism) measured from blood samples at the specified time points
Time frame: Study Days: 1, 2, 4, 8, 11, 15, 18, 22, 29