FT516 in Combination With Monoclonal Antibodies in 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.
Checked against the public recordLast updated Sep 21, 2023 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Fate Therapeutics
- Interventions being studied
- Drug: FT516; Drug: Avelumab; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: IL-2
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of Minnesota Masonic Cancer CenterMinneapolis, Minnesota
- Hackensack University Medical Center/John Theurer Cancer CenterHackensack, New Jersey
- MD Anderson Cancer CenterHouston, Texas
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 21, 2023. Always confirm current availability with the study team.