FT516 in Combination With Monoclonal Antibodies in Advanced Solid Tumors

A Phase I, Open-Label, Multicenter Study of FT516 in Combination With Monoclonal Antibodies in Subjects With Advanced Solid Tumors

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

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