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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.
 
ClinicalTrials.gov Identifier: NCT04551885
Recruitment Status : Active, not recruiting
First Posted : September 16, 2020
Last Update Posted : May 1, 2023
Sponsor:
Information provided by (Responsible Party):
Fate Therapeutics

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Solid Tumor, Adult Drug: FT516 Drug: Avelumab Drug: Cyclophosphamide Drug: Fludarabine Drug: IL-2 Phase 1

Study Design
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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
Actual Primary Completion Date : January 15, 2023
Estimated Study Completion Date : January 25, 2037

Resource links provided by the National Library of Medicine

Drug Information available for: Avelumab

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Dose-Limiting Toxicities (DLTs) Within Each Dose Level Cohort [ Time Frame: Up to Day 29 after the end of Cycle 1 (each cycle is 28 days) ]
    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.

  2. Severity of DLTs Within Each Dose Level Cohort [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]
    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.


Secondary Outcome Measures :
  1. Number of Participants with ≥1 Adverse Events (AE) [ Time Frame: Up to 15 years ]
    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.

  2. Investigator-Assessed Duration of Response (DOR) [ Time Frame: Up to 15 years ]
    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.

  3. Disease Control Rate (DCR) [ Time Frame: Up to 15 years ]
    DCR is defined as the percentage of participants 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 ]
    PFS is defined as 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 ]
    OS is defined as 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


Eligibility Criteria
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Information from the National Library of Medicine

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

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
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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 ClinicalTrials.gov identifier (NCT number): NCT04551885


Locations
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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
Investigators
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Study Director: Fate Trial Disclosure Fate Therapeutics
More Information
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Publications:

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Responsible Party: Fate Therapeutics
ClinicalTrials.gov Identifier: NCT04551885    
Other Study ID Numbers: FT516-102
First Posted: September 16, 2020    Key Record Dates
Last Update Posted: May 1, 2023
Last Verified: April 2023
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:
PD-L1
cellular therapy
NK cells
urothelial cancer
renal cell carcinoma
 merkel cell carcinoma
non-small cell lung cancer
NSCLC
triple negative breast cancer
immune checkpoint inhibitor
Additional relevant MeSH terms:
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Neoplasms
Aldesleukin
Cyclophosphamide
Fludarabine
Avelumab
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