FT516 in Combination With Monoclonal Antibodies in Advanced Solid Tumors

• Status: Recruiting
• Trial end date: 2037-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fate Therapeutics
• Treatments: Aldesleukin; Avelumab; Cyclophosphamide; Fludarabine

Criteria

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