FT516 in Combination With Monoclonal Antibodies in Advanced Solid Tumors

Sponsor
Fate Therapeutics (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04551885
Collaborator
(none)
12
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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
Phase 1

Study Design

Study Type:
Interventional
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 :
Sep 7, 2020
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Aug 1, 2037

Arms and Interventions

Arm Intervention/Treatment
Experimental: FT516 in combination with avelumab

Drug: FT516
Experimental Interventional Therapy

Drug: Avelumab
Monoclonal antibody
Other Names:
  • Bavencio
  • Drug: Cyclophosphamide
    Lympho-conditioning agent

    Drug: Fludarabine
    Lympho-conditioning agent

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

    Primary Outcome Measures

    1. Incidence of dose-limiting toxicities within each dose level cohort [At the end of Cycle 1 (each cycle is 28 days)]

    2. Nature of dose-limiting toxicities within each dose level cohort [At the end of Cycle 1 (each cycle is 28 days)]

    Secondary Outcome Measures

    1. Incidence, nature and severity of adverse events [Up to 15 years]

    2. 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

    3. 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

    4. 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.

    5. Overall Survival (OS) [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 [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

    Ages Eligible for Study:
    18 Years and Older
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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

    Responsible Party:
    Fate Therapeutics
    ClinicalTrials.gov Identifier:
    NCT04551885
    Other Study ID Numbers:
    • FT516-102
    First Posted:
    Sep 16, 2020
    Last Update Posted:
    Nov 15, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Fate Therapeutics
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 15, 2021