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FT516 in Combination With Monoclonal Antibodies in Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04551885
Recruitment Status : Active, not recruiting
First Posted : September 16, 2020
Last Update Posted : November 15, 2021
Information provided by (Responsible Party):
Fate Therapeutics

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
Solid Tumor, Adult Drug: FT516 Drug: Avelumab Drug: Cyclophosphamide Drug: Fludarabine Drug: IL-2 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open-Label, Multicenter Study of FT516 in Combination With Monoclonal Antibodies in Subjects With Advanced Solid Tumors
Actual Study Start Date : September 7, 2020
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2037

Arm Intervention/treatment
Experimental: FT516 in combination with avelumab Drug: FT516
Experimental Interventional Therapy

Drug: Avelumab
Monoclonal antibody
Other Name: Bavencio

Drug: Cyclophosphamide
Lympho-conditioning agent

Drug: Fludarabine
Lympho-conditioning agent

Drug: IL-2
Biologic response modifier
Other Names:
  • Proleukin
  • Aldesleukin

Primary Outcome Measures :
  1. Incidence of dose-limiting toxicities within each dose level cohort [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]
  2. Nature of dose-limiting toxicities within each dose level cohort [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]

Secondary Outcome Measures :
  1. Incidence, nature and severity of adverse events [ Time Frame: Up to 15 years ]
  2. Investigator-assessed duration of response (DOR) [ Time Frame: 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

  3. Disease control rate [ Time Frame: Up to 15 years ]
    Proportion of subjects with Stable Disease more than 6 months, Partial Response or Complete Response, per iRECIST response criteria

  4. Progression Free Survival (PFS) [ Time Frame: 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.

  5. Overall Survival (OS) [ Time Frame: Up to 15 years ]
    The time from first dose of lympho-conditioning to death from any cause

  6. Determination of PK of FT516 in peripheral blood [ Time Frame: 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04551885

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United States, Minnesota
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, United States, 55455
United States, New Jersey
Hackensack University Medical Center/John Theurer Cancer Center
Hackensack, New Jersey, United States, 07601
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Fate Therapeutics
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Study Director: Jeff Chou, MD Fate Therapeutics
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Responsible Party: Fate Therapeutics Identifier: NCT04551885    
Other Study ID Numbers: FT516-102
First Posted: September 16, 2020    Key Record Dates
Last Update Posted: November 15, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fate Therapeutics:
cellular therapy
NK cells
urothelial cancer
renal cell carcinoma
merkel cell carcinoma
non-small cell lung cancer
triple negative breast cancer
immune checkpoint inhibitor
Additional relevant MeSH terms:
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Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Antineoplastic Agents, Immunological