FT516 in Combination With Monoclonal Antibodies in Advanced Solid Tumors

Fate Therapeutics

Status and phase

Terminated

Phase 1

Conditions

Solid Tumor, Adult

Treatments

Drug: FT516

Drug: IL-2

Drug: Fludarabine

Drug: Cyclophosphamide

Drug: Avelumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT04551885

FT516-102

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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