FT516 in Combination With Monoclonal Antibodies in Advanced Solid Tumors

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedFT516 and Avelumab

Plus 3 other study approaches.

Who it may be forSolid Tumor, Adult

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 21, 2023 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?3 U.S. locations

Locations may change over time.

Who runs it?Fate Therapeutics

Study sponsor

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

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How this study is categorized

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

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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.

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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