FT516 in Combination With Monoclonal Antibodies in Advanced Solid Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-07

Study Completion Date

2023-08-11

Brief Summary

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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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Detailed Description

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Conditions

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Solid Tumor, Adult

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FT516 in combination with avelumab

Group Type EXPERIMENTAL

FT516

Intervention Type DRUG

Experimental Interventional Therapy

Avelumab

Intervention Type DRUG

Monoclonal antibody

Cyclophosphamide

Intervention Type DRUG

Lympho-conditioning agent

Fludarabine

Intervention Type DRUG

Lympho-conditioning agent

IL-2

Intervention Type DRUG

Biologic response modifier

Interventions

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FT516

Experimental Interventional Therapy

Intervention Type DRUG

Avelumab

Monoclonal antibody

Intervention Type DRUG

Cyclophosphamide

Lympho-conditioning agent

Intervention Type DRUG

Fludarabine

Lympho-conditioning agent

Intervention Type DRUG

IL-2

Biologic response modifier

Intervention Type DRUG

Other Intervention Names

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Bavencio Proleukin Aldesleukin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No