FT516 in Combination With Monoclonal Antibodies in Advanced Solid Tumors
Stopped early · Phase 1
Conditions studied: Solid Tumor, Adult
In brief
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.
Key facts
- Study ID
- NCT04551885
- Run by
- Fate Therapeutics
- People needed
- 12
- Starts
- 2020-09-07
- Expected to finish
- 2023-08-11
- Last updated by the study team
- 2023-09-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Minnesota Masonic Cancer Center — Minneapolis, Minnesota, United States
- Hackensack University Medical Center/John Theurer Cancer Center — Hackensack, New Jersey, United States
- MD Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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