This is a Phase 1 dose-finding study of FT538 in combination with monoclonal antibodies.
This is a Phase 1 dose-finding study of FT538 given in combination with a monoclonal antibody following lymphodepletion in subjects with advanced solid tumors. 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
16
FT538 is an allogeneic natural killer (NK)-cell immunotherapy
Lympho-conditioning agent
Lympho-conditioning agent
Hackensack University Medical Center
Hackensack, New Jersey, United States
Sarah Cannon
Nashville, Tennessee, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
NEXT Oncology
San Antonio, Texas, United States
Define the Recommended Phase 2 Dose (RP2D)
To define the RP2D of FT538 in combination with the following mAbs in subjects with advanced solid tumors: avelumab, trastuzumab, cetuximab, atezolizumab, nivolumab, and pembrolizumab
Time frame: Up to ~1.5 years
Incidence and Severity of Adverse Events (AEs)0
To evaluate the safety and tolerability of FT538 in combination with the following mAbs in subjects with advanced solid tumors: avelumab, trastuzumab, cetuximab, atezolizumab, nivolumab, and pembrolizumab
Time frame: Up to ~5 years
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either avelumab, trastuzumab or cetuximab
either avelumab, atezolizumab, nivolumab, pembrolizumab, trastuzumab or cetuximab