TerminatedPhase 1NCT04551885

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

StatusTerminated
PhasePhase 1
U.S. locations3
SponsorFate Therapeutics
01
Study overview

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
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

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.

04
Study sites

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.

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