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FT516 in Combination With Monoclonal Antibodies in Advanced Solid Tumors

Trial Status: Active

This is a Phase 1 dose-finding study of FT-516 in combination with monoclonal antibodies 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.

Inclusion Criteria

  • Locally advanced or metastatic solid tumor malignancies that have relapsed or progressed after at least one line of therapy and where the following anti-PD-L1 are approved: avelumab, atezolizumab or durvalumab
  • Capable of giving signed informed consent
  • Aged ≥ 18 years old
  • Willingness to comply with study procedures and duration
  • Measurable disease per iRECIST
  • Contraceptive use for women and men as defined in the protocol

Exclusion Criteria

  • Pregnant or breast-feeding women
  • ECOG performance status ≥ 2
  • Evidence of insufficient organ function
  • Clinically significant cardiovascular disease
  • Receipt of therapy within 2 weeks prior to Day 1 or five half-lives, whichever is shorter or any investigational therapy within 28 days prior to Day 1
  • Known active central nervous system (CNS) involvement by malignancy
  • Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis or neurodegenerative disease or receipt of medications for these conditions
  • Currently receiving or likely to require immunosuppressive therapy
  • Known active infections with Hepatitis B, Hepatitis C or HIV
  • Live vaccine within 6 weeks prior to start of lympho-conditioning
  • Known allergy to albumin (human) or DMSO

Minnesota

Minneapolis
University of Minnesota / Masonic Cancer Center
Status: ACTIVE

New Jersey

Hackensack
Hackensack University Medical Center
Status: ACTIVE

Texas

Houston
M D Anderson Cancer Center
Status: ACTIVE

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Fate Therapeutics

  • Primary ID FT516-102
  • Secondary IDs NCI-2020-09080
  • Clinicaltrials.gov ID NCT04551885