FT516 in Combination With Monoclonal Antibodies in Advanced Solid Tumors

Phase 1TerminatedNCT04551885

Fate Therapeutics12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Solid Tumor, Adult

Interventions

FT516DRUG

Experimental Interventional Therapy

AvelumabDRUG

Monoclonal antibody

CyclophosphamideDRUG

Lympho-conditioning agent

Fludarabine

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

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

Outcomes

Primary Outcomes

Incidence of Dose-Limiting Toxicities (DLTs) Within Each Dose Level Cohort

The incidence of DLTs within each dose level cohort will be reported. A DLT is any adverse event (AE) that is at least possibly related to FT516 that occurs after the first FT516 infusion through the end of the DLT assessment period on Cycle 1 Day 29, and meets 1 of the criteria from the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 or the American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading Guidelines for Cytokine Release Syndrome and Neurological Toxicity Associated with Immune Effector Cells.

Time frame: Up to Day 29 after the end of Cycle 1 (each cycle is 28 days)

Severity of DLTs Within Each Dose Level Cohort

The severity of DLTs within each cohort will be reported. DLT is any adverse event (AE) that is at least possibly related to FT516 that occurs after the first FT516 infusion through the end of the DLT assessment period on Cycle 1 Day 29, and meets 1 of the criteria from the NCI CTCAE v5.0 or the ASTCT Consensus Grading Guidelines for Cytokine Release Syndrome and Neurological Toxicity Associated with Immune Effector Cells.

Time frame: At the end of Cycle 1 (each cycle is 28 days)

Secondary Outcomes

Number of Participants with ≥1 Adverse Events (AE)

An AE is any untoward medical occurrence in a participants temporally associated with the use of study treatment, whether or not considered related to the study treatment.

Time frame: Up to 15 years

Investigator-Assessed Duration of Response (DOR)

DOR is the time from the first occurrence of a documented, objective response until the time of disease progression, relapse or death from any cause, whichever occurs first, per modified Response Evaluation Criteria in Solid Tumors (iRECIST) response criteria.

Time frame: Up to 15 years

Data from ClinicalTrials.gov

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