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FT516 in Subjects With Advanced Hematologic Malignancies

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: NCT04023071
Recruitment Status : Active, not recruiting
First Posted : July 17, 2019
Last Update Posted : May 3, 2023
Sponsor:
Information provided by (Responsible Party):
Fate Therapeutics

Study Description
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Brief Summary:
This is a Phase 1/1b dose-finding study of FT516 as monotherapy in acute myeloid leukemia (AML) and in combination with CD20 directed monoclonal antibodies in B-cell lymphoma. The study includes three stages: dose escalation, safety confirmation, and dose expansion.

Condition or disease Intervention/treatment Phase
Acute Myelogenous Leukemia B-cell Lymphoma Drug: FT516 Drug: Rituximab Drug: Obinutuzumab Drug: Cyclophosphamide Drug: Fludarabine Drug: IL-2 Drug: Bendamustine Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of FT516 as Monotherapy in Relapsed/Refractory Acute Myelogenous Leukemia and in Combination With Monoclonal Antibodies in Relapsed/Refractory B-Cell Lymphoma
Actual Study Start Date : October 4, 2019
Estimated Primary Completion Date : May 2024
Estimated Study Completion Date : May 2039

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: FT516 Monotherapy
FT516 monotherapy in adult subjects with r/r AML.
 Drug: FT516
Experimental Interventional Therapy

Drug: Cyclophosphamide
Conditioning agent

Drug: Fludarabine
Conditioning agent

Drug: IL-2
Biologic response modifier
Experimental: FT516 in Combination with Monoclonal Antibodies
FT516 in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab.
 Drug: FT516
Experimental Interventional Therapy

Drug: Rituximab
Monoclonal Antibody
Other Names:
  • Rituxan
  • MabThera

Drug: Obinutuzumab
Monoclonal Antibody
Other Name: Gazyva

Drug: Cyclophosphamide
Conditioning agent

Drug: Fludarabine
Conditioning agent

Drug: IL-2
Biologic response modifier
Experimental: FT516 in Combination with Monoclonal Antibodies on an Extended-Dosing Schedule
FT516 on an extended-dosing schedule in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab.
 Drug: FT516
Experimental Interventional Therapy

Drug: Rituximab
Monoclonal Antibody
Other Names:
  • Rituxan
  • MabThera

Drug: Obinutuzumab
Monoclonal Antibody
Other Name: Gazyva

Drug: Cyclophosphamide
Conditioning agent

Drug: Fludarabine
Conditioning agent

Drug: IL-2
Biologic response modifier
Experimental: FT516 in Combination with Monoclonal Antibodies following Bendamustine Conditioning
Bendamustine conditioning followed by FT516 in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab.
 Drug: FT516
Experimental Interventional Therapy

Drug: Rituximab
Monoclonal Antibody
Other Names:
  • Rituxan
  • MabThera

Drug: Obinutuzumab
Monoclonal Antibody
Other Name: Gazyva

Drug: IL-2
Biologic response modifier

Drug: Bendamustine
Conditioning agent
Other Names:
  • Bendeka
  • Treanda


Outcome Measures
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Primary Outcome Measures :
  1. The incidence of subjects with Dose Limiting Toxicities within each dose level cohort. [ Time Frame: Day 29 ]
  2. Incidence, nature, and severity of AEs, of FT516 as monotherapy in r/r AML and in combination with rituximab or obinutuzumab in r/r B-cell lymphoma. [ Time Frame: Up to 5 years ]

Secondary Outcome Measures :
  1. Investigator-assessed anti-tumor activity of FT516 as monotherapy in r/r AML and in combination with rituximab or obinutuzumab in r/r B-cell lymphoma. [ Time Frame: Cycle 2 Day 29 ]
  2. FT516 pharmacokinetic data [ Time Frame: Cycle 1 and Cycle 2 Study Days: 1, 2, 4, 8, 11, 15, 18, 22, 29, and Cycle 2 Day 43 and Cycle 2 Day 57. ]
    Percentage of donor DNA measured at each timepoint


Eligibility Criteria
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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

KEY INCLUSION CRITERIA:

Diagnosis of the following:

Regimen A (FT516 monotherapy):

  • Primary Refractory AML
  • Relapsed AML defined as not in CR after 1 or more re-induction attempts; if >60 years of age, prior re-induction therapy is not required

Regimen B (FT516 + rituximab or obinutuzumab):

  • Histologically documented B-cell lymphoma expected to express CD20 who have relapsed after or failed to respond to at least on prior treatment regimen and for whom there is no available therapy expected to improve survival.

All subjects:

  • Provision of signed and dated informed consent form (ICF)
  • Age ≥18 years old
  • Stated willingness to comply with study procedures and duration
  • Presence of measurable disease

KEY EXCLUSION CRITERIA:

All subjects:

  • Females of reproductive potential who are pregnant or lactating, and males or females not willing to use a highly effective form of contraception from Screening through the end of the study
  • Eastern Cooperative Oncology Group (ECOG) Performance Status ≥2
  • Evidence of insufficient organ function
  • Receipt of therapy within 2 weeks prior to Cycle 1 Day 1 or within five half-lives, whichever is shorter; or any investigational therapy within 28 days prior to Cycle 1 Day 1
  • Currently receiving or likely to require systemic immunosuppressive therapy
  • Prior allogeneic HSCT or allogeneic CAR-T within 6 months of Cycle 1 Day 1, or ongoing requirement for systemic graft-versus-host therapy
  • Receipt of an allograft organ transplant
  • Known active central nervous system (CNS) involvement by malignancy.
  • Clinically significant cardiovascular disease
  • Clinically significant infections including: Known HIV infection; Known active Hepatitis B (HBV) or Hepatitis C (HCV) infection
  • Live vaccine <6 weeks prior to start of lympho-conditioning
  • Known allergy to human albumin and DMSO

Additional Exclusion Criteria for FT516 monotherapy Regimen: Diagnosis of promyelocytic leukemia with t(15:17) translocation

Additional Exclusion Criteria for FT516 plus monoclonal antibody Regimens: Diagnosis of Waldenstrom macroglobulinemia

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): NCT04023071


Locations
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United States, Arizona
Mayo Clinic
Phoenix, Arizona, United States, 85054
United States, California
UC San Diego
San Diego, California, United States, 92037
United States, Colorado
University of Colorado, Denver
Denver, Colorado, United States, 80045
United States, Minnesota
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, United States, 55455
United States, Texas
UT Southwestern
Dallas, Texas, United States, 75390
MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Washington
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Fate Therapeutics
Investigators
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Study Director: Fate Trial Disclosure Fate Therapeutics
More Information
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Responsible Party: Fate Therapeutics
ClinicalTrials.gov Identifier: NCT04023071    
Other Study ID Numbers: FT516-101
First Posted: July 17, 2019    Key Record Dates
Last Update Posted: May 3, 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:
AML
Lymphoma
Additional relevant MeSH terms:
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Lymphoma
Leukemia
Lymphoma, B-Cell
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Cyclophosphamide
Bendamustine Hydrochloride
 Rituximab
Fludarabine
Obinutuzumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological