Clinical Trials /

FT516 in Subjects With Advanced Hematologic Malignancies

NCT04023071

Description:

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 will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-sepcific cohorts.

Related Conditions:
  • Acute Myeloid Leukemia
  • B-Cell Non-Hodgkin Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: FT516 in Subjects With Advanced Hematologic Malignancies
  • 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

Clinical Trial IDs

  • ORG STUDY ID: FT516-101
  • NCT ID: NCT04023071

Conditions

  • Acute Myelogenous Leukemia
  • B-cell Lymphoma

Interventions

DrugSynonymsArms
FT516FT516 Monotherapy
RituximabRituxan, MabTheraFT516 in Combination with Monoclonal Antibodies
ObinutuzumabGazyvaFT516 in Combination with Monoclonal Antibodies
CyclophosphamideFT516 Monotherapy
FludarabineFT516 Monotherapy
IL-2FT516 Monotherapy

Purpose

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 will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-sepcific cohorts.

Trial Arms

NameTypeDescriptionInterventions
FT516 MonotherapyExperimentalFT516 monotherapy in adult subjects with r/r AML.
  • FT516
  • Cyclophosphamide
  • Fludarabine
  • IL-2
FT516 in Combination with Monoclonal AntibodiesExperimentalFT516 in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab.
  • FT516
  • Rituximab
  • Obinutuzumab
  • Cyclophosphamide
  • Fludarabine
  • IL-2

Eligibility 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

          -  Provision of signed and dated ICF to agree to participate, at time of withdrawal or
             completion of this study, in Fate Therapeutics' long-term follow-up study.

        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

          -  QTc >450 msec on screening ECG

        Additional Exclusion Criteria for Regimen A (FT516 monotherapy): Diagnosis of promyelocytic
        leukemia with t(15:17) translocation
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:The incidence of subjects with Dose Limiting Toxicities within each dose level cohort.
Time Frame:Day 29
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Incidence and nature 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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure:Objective response rate (ORR) 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
Safety Issue:
Description:
Measure:FT516 pharmacokinetic data
Time Frame:Cycle 1 and Cycle 2 Study Days: 1, 4, 8, 11, 15, 18, 22, 29, and Cycle 2 Day 43 and Cycle 2 Day 57.
Safety Issue:
Description:Percentage of donor DNA measured at each timepoint

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Fate Therapeutics

Trial Keywords

  • AML
  • Lymphoma

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