This is a Phase 1 dose-finding study of FT536 given in combination with a monoclonal antibody following lymphodepletion in participants 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
5
FT536 is an allogeneic natural killer (NK)-cell immunotherapy
Lympho-conditioning agent
Lympho-conditioning agent
For Cohort AA ONLY: To be combined with FT536 at the MTD or MAD
Monoclonal antibody
For Cohorts C/CC, the combination product (monoclonal antibody) will be ONE of the following: pembrolizumab, nivolumab, or atezolizumab.
For Cohorts C/CC, the combination product (monoclonal antibody) will be ONE of the following: pembrolizumab, nivolumab, or atezolizumab.
For Cohorts C/CC, the combination product (monoclonal antibody) will be ONE of the following: pembrolizumab, nivolumab, or atezolizumab.
Monoclonal antibody
Monoclonal antibody
Monoclonal antibody
For Cohorts BB-FF ONLY: To be combined with FT536 + mAb at the MTD or MAD
Honor Health Research Institute
Scottsdale, Arizona, United States
UCLA Division of Hematology-Oncology
Los Angeles, California, United States
Hackensack University Medical Center - John Theurer Cancer Center
Hackensack, New Jersey, United States
Carolina BioOncology Institute
Huntersville, North Carolina, United States
NEXT Oncology
San Antonio, Texas, United States
Determine the Recommended Phase 2 Dose (RP2D)
The RP2Ds of FT536 monotherapy and FT536 + monoclonal antibody (mAbs) will be determined. The RP2D will be determined based on the overall safety and efficacy profile.
Time frame: Up to approximately 3 years
Number of Participants with ≥ Adverse Event (AE) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v5.0
The safety and tolerability of FT536 monotherapy and in combination with mAbs will be determined.
Time frame: Following enrollment completion within dose escalation and expansion, approximately 3 years
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