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FT538 in Subjects With Advanced Hematologic Malignancies

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ClinicalTrials.gov Identifier: NCT04614636
Recruitment Status : Recruiting
First Posted : November 4, 2020
Last Update Posted : May 25, 2022
Sponsor:
Information provided by (Responsible Party):
Fate Therapeutics

Brief Summary:
This is a Phase I dose-finding study of FT538 as monotherapy in acute myeloid leukemia (AML) and in combination with monoclonal antibodies in multiple myeloma (MM). 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
Acute Myeloid Leukemia AML, Adult Multiple Myeloma Myeloma Drug: FT538 Drug: Cyclophosphamide Drug: Fludarabine Drug: Daratumumab Drug: Elotuzumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open-Label, Multicenter Study of FT538 as Monotherapy in Relapsed/Refractory Acute Myelogenous Leukemia and in Combination With Monoclonal Antibodies in Relapsed/Refractory Multiple Myeloma
Actual Study Start Date : October 17, 2020
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2038


Arm Intervention/treatment
Experimental: FT538 Monotherapy
FT538 monotherapy in subjects with r/r AML
Drug: FT538
Experimental Interventional Therapy, Allogeneic Cell Therapy NK Cell

Drug: Cyclophosphamide
Lympho-conditioning Agent

Drug: Fludarabine
Lympho-conditioning Agent

Experimental: FT538 in Combination with Daratumumab
FT538 in combination with daratumumab in subjects with r/r MM
Drug: FT538
Experimental Interventional Therapy, Allogeneic Cell Therapy NK Cell

Drug: Cyclophosphamide
Lympho-conditioning Agent

Drug: Fludarabine
Lympho-conditioning Agent

Drug: Daratumumab
Monoclonal Antibody, CD38, Anti-CD38
Other Name: Darzalex

Experimental: FT538 in Combination with Elotuzumab
FT538 in combination with elotuzumab in subjects with r/r MM
Drug: FT538
Experimental Interventional Therapy, Allogeneic Cell Therapy NK Cell

Drug: Cyclophosphamide
Lympho-conditioning Agent

Drug: Fludarabine
Lympho-conditioning Agent

Drug: Elotuzumab
Monoclonal Antibody
Other Name: Empliciti




Primary Outcome Measures :
  1. Incidence of dose-limiting toxicities within each dose level cohort [ Time Frame: Cycle 1, Day 29 ]
  2. Nature of dose-limiting toxicities within each dose level cohort [ Time Frame: Cycle 1, Day 29 ]

Secondary Outcome Measures :
  1. Incidence, nature, and severity of adverse events (AEs) of FT538 as monotherapy in r/r AML and in combination with daratumumab or elotuzumab in r/r multiple myeloma [ Time Frame: Up to 5 years ]
  2. Objective response rate (ORR) of FT538 as monotherapy in r/r AML and in combination with daratumumab or elotuzumab in r/r MM [ Time Frame: From baseline tumor assessment up to approximately 2 years after last dose of FT538 ]
    Proportion of subjects who achieve a CR, CRMRD-, CRi, MLFS, or PR, as determined by the investigator according to 2017 ELN criteria for AML, and the proportion of subjects with a best overall response of sCR, CR, VGPR, or PR, as determined by the investigator according to standard IMWG for MM response criteria

  3. Duration of response (DOR) of FT538 in combination with daratumumab or elotuzumab in r/r MM [ Time Frame: Up to 15 years ]
    Defined as the duration from the first occurrence of a documented objective response until the time of disease progression or relapse, or death due to progressive disease, as determined by the investigator according to standard IMWG response criteria

  4. Progression-free survival (PFS) of FT538 in combination with daratumumab or elotuzumab in r/r MM [ Time Frame: Up to 15 years ]
    Defined as the time from first dose of study treatment to disease progression or relapse, or to the day of death from any cause, as determined by the investigator according to standard IMWG response criteria

  5. Relapse-free survival (RFS) of FT538 as monotherapy in r/r AML and in combination with daratumumab or elotuzumab in r/r MM [ Time Frame: Up to 15 years ]
    Defined as the time from initial CR (including CRMRD-, CR, and CRi) to hematologic relapse or death due to any cause, as determined by the investigator according to 2017 ELN criteria for AML, and defined as the duration from the start of sCR or CR until the time of relapse from sCR or CR, as determined by the investigator according to standard IMWG response criteria for MM

  6. Event-free survival (EFS) of FT538 as monotherapy in r/r AML [ Time Frame: Up to 15 years ]
    defined as the time from first dose of lympho-conditioning to the date of PD, or relapse from CR or CRi, or death from any cause, according to 2017 ELN criteria

  7. Overall survival (OS) of FT538 as monotherapy in r/r AML and in combination with daratumumab or elotuzumab in r/r MM [ Time Frame: Up to 15 years ]
    defined as the time from first dose of lympho-conditioning to death from any cause

  8. Time-to-best response of FT538 as monotherapy in r/r AML [ Time Frame: Up to 15 years ]
    defined as the time from first dose of lympho-conditioning to best response

  9. Determination of the pharmacokinetics (PK) of FT538 cells in peripheral blood [ Time Frame: Study Days: 1, 2, 4, 8, 11, 15, 18, 22, 29 ]
    The PK of FT538 in peripheral blood will be reported as the relative percentage of product (FT538) DNA versus patient DNA (% chimerism) measured from blood samples at the specified time points



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:

  1. Diagnosis of one of the following by treatment regimen:

    Regimen A (FT538 monotherapy in r/r AML)

    • Primary refractory AML, or
    • Relapsed AML, defined as not in CR after one or more re-induction attempts; if >60 years of age, prior re-induction therapy is not required

    Regimens B or C (FT538 + mAb in r/r MM)

    • Regimen B only: MM that has relapsed or progressed after at least two lines of therapies, including a proteasome inhibitor and an immunomodulatory drug
    • Regimen C only: MM that has relapsed or progressed after proteasome inhibitor therapy, and immunomodulatory therapy
    • Regimen B and Regimen C: Measurable disease as defined in the protocol
  2. Capable of giving signed informed consent
  3. Age ≥18 years old
  4. Agreement to comply with study procedures as described in the Schedule of Activities
  5. Contraceptive use as described in the protocol

Exclusion Criteria:

  1. Females who are pregnant or breastfeeding
  2. ECOG Performance Status ≥ 2
  3. Evidence of insufficient hematologic function as defined in the protocol
  4. Evidence of insufficient organ function defined as defined by the protocol
  5. Clinically significant cardiovascular disease as defined by the protocol
  6. Known active central nervous system (CNS) involvement by malignancy
  7. Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease or receipt of medications for these conditions in the 2-year period leading up to study enrollment
  8. Currently receiving or likely to require systemic immunosuppressive therapy for any reason during the treatment period
  9. Clinically significant infections including HIV, HBV and HCV
  10. Live vaccine <6 weeks prior to start of lympho-conditioning
  11. Receipt of an allograft organ transplant
  12. Prior allogeneic HSCT or allogeneic CAR-T within 6 months of Day 1, or ongoing requirement for systemic graft-versus-host therapy
  13. Known allergy to albumin (human) or DMSO
  14. Presence of any medical or social issues that are likely to interfere with study conduct or may cause increased risk to subject
  15. Any medical condition or clinical laboratory abnormality that per investigator or Medical Monitor judgement precludes safe participation in and completion of the study, or which could affect compliance with protocol conduct or interpretation of results

    Exclusion Criteria Specific to Regimen A (r/r AML)

  16. Diagnosis of promyelocytic leukemia with t(15;17) translocation
  17. Receipt of any biological therapy, chemotherapy, or radiation therapy, except for palliative purposes, 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

    Exclusion Criteria Specific to Regimens B and C (r/r MM)

  18. Plasma cell leukemia defined as a plasma cell count >2000/mm3
  19. Leptomeningeal involvement of MM
  20. Receipt of any biological therapy, chemotherapy, or radiation therapy, except for palliative purposes, within 2 weeks prior to Day 1 or five half-lives, whichever is shorter; or any investigational therapy within 28 days prior to the first dose of mAb
  21. Allergy or hypersensitivity to antibodies or antibody-related proteins

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): NCT04614636


Contacts
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Contact: Mohamed Elgendy 8588751800 clinical@fatetherapeutics.com
Contact: Dennis Hazekamp 8588751800 clinical@fatetherapeutics.com

Locations
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United States, Colorado
Colorado Blood Cancer Institute Recruiting
Denver, Colorado, United States, 80218
United States, Minnesota
University of Minnesota Masonic Cancer Center Recruiting
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
United States, New Jersey
John Theurer Cancer Center at Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
United States, Tennessee
Tennessee Oncology Nashville Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
St. David's South Austin Medical Center Recruiting
Austin, Texas, United States, 78704
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Texas Transplant Institute Recruiting
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Fate Therapeutics
Investigators
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Study Director: John Byon, MD Fate Therapeutics, Inc
Additional Information:
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Responsible Party: Fate Therapeutics
ClinicalTrials.gov Identifier: NCT04614636    
Other Study ID Numbers: FT538-101
First Posted: November 4, 2020    Key Record Dates
Last Update Posted: May 25, 2022
Last Verified: May 2022
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:
Acute Myeloid Leukemia
AML
Multiple Myeloma
daratumumab
elotuzumab
NK cell
cellular therapy
allogeneic cell therapy
allogeneic cellular therapy
CD38
Anti-CD38
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Multiple Myeloma
Neoplasms, Plasma Cell
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Fludarabine
Daratumumab
Elotuzumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists