FT516 in Combination With Monoclonal Antibodies in Advanced Solid Tumors
Study Details
Study Description
Brief Summary
This is a Phase 1 dose-finding study of FT-516 in combination with monoclonal antibodies in subjects 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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: FT516 in combination with avelumab
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Drug: FT516
Experimental Interventional Therapy
Drug: Avelumab
Monoclonal antibody
Other Names:
Drug: Cyclophosphamide
Lympho-conditioning agent
Drug: Fludarabine
Lympho-conditioning agent
Drug: IL-2
Biologic response modifier
Other Names:
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Outcome Measures
Primary Outcome Measures
- Incidence of dose-limiting toxicities within each dose level cohort [At the end of Cycle 1 (each cycle is 28 days)]
- Nature of dose-limiting toxicities within each dose level cohort [At the end of Cycle 1 (each cycle is 28 days)]
Secondary Outcome Measures
- Incidence, nature and severity of adverse events [Up to 15 years]
- Investigator-assessed duration of response (DOR) [Up to 15 years]
Duration of the first occurrence of a documented, objective response until the time of disease progression, relapse or death from any cause, whichever occurs first, per iRECIST
- Disease control rate [Up to 15 years]
Proportion of subjects with Stable Disease more than 6 months, Partial Response or Complete Response, per iRECIST response criteria
- Progression Free Survival (PFS) [Up to 15 years]
The time from first dose of lympho-conditioning to disease progression or to the day of death for any reason, whichever occurs first, per iRECIST response criteria.
- Overall Survival (OS) [Up to 15 years]
The time from first dose of lympho-conditioning to death from any cause
- Determination of PK of FT516 in peripheral blood [Study Days 1, 2, 4, 8, 11, 18, 22, 29]
The pharmacokinetics of FT516 in peripheral blood will be reported as the relative percentage of product (FT516) DNA versus patient DNA (% chimerism) measured from blood samples at the specified time points
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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Capable of giving signed informed consent
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Aged ≥ 18 years old
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Willingness to comply with study procedures and duration
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Measurable disease per iRECIST
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Contraceptive use for women and men as defined in the protocol
Exclusion Criteria:
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Pregnant or breast-feeding women
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ECOG performance status ≥ 2
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Evidence of insufficient organ function
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Clinically significant cardiovascular disease
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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
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Known active central nervous system (CNS) involvement by malignancy
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Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis or neurodegenerative disease or receipt of medications for these conditions
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Currently receiving or likely to require immunosuppressive therapy
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Known active infections with Hepatitis B, Hepatitis C or HIV
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Live vaccine within 6 weeks prior to start of lympho-conditioning
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Known allergy to albumin (human) or DMSO
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | University of Minnesota Masonic Cancer Center | Minneapolis | Minnesota | United States | 55455 |
2 | Hackensack University Medical Center/John Theurer Cancer Center | Hackensack | New Jersey | United States | 07601 |
3 | MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- Fate Therapeutics
Investigators
- Study Director: Jeff Chou, MD, Fate Therapeutics
Study Documents (Full-Text)
None provided.More Information
Publications
- FT516-102