FT516 in Subjects With Advanced Hematologic Malignancies

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

Tracking Information

• First Submitted Date: July 9, 2019
• First Posted Date: July 17, 2019
• Last Update Posted Date: May 3, 2023
• Actual Study Start Date: October 4, 2019
• Estimated Primary Completion Date: May 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 22, 2021)

• The incidence of subjects with Dose Limiting Toxicities within each dose level cohort. [ Time Frame: Day 29 ]
• 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 ]

• Original Primary Outcome Measures (submitted: July 15, 2019): The incidence of subjects with Dose Limiting Toxicities within each dose level cohort. [ Time Frame: Day 29 ]

Current Secondary Outcome Measures (submitted: December 22, 2021)

• 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 ]
• 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

Original Secondary Outcome Measures (submitted: July 15, 2019)

• 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 ]
• 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 ]
• 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 ]
• 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. ]
  Percentage of donor DNA measured at each timepoint

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Acute Myelogenous Leukemia
• B-cell Lymphoma

Intervention

• 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
• Drug: Bendamustine
  Conditioning agent
  Other Names:

  • Bendeka
  • Treanda

Study Arms

• Experimental: FT516 Monotherapy
  FT516 monotherapy in adult subjects with r/r AML.
  Interventions:

  • Drug: FT516
  • Drug: Cyclophosphamide
  • Drug: Fludarabine
  • Drug: IL-2
• 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.
  Interventions:

  • Drug: FT516
  • Drug: Rituximab
  • Drug: Obinutuzumab
  • Drug: Cyclophosphamide
  • Drug: Fludarabine
  • Drug: IL-2
• 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.
  Interventions:

  • Drug: FT516
  • Drug: Rituximab
  • Drug: Obinutuzumab
  • Drug: Cyclophosphamide
  • Drug: Fludarabine
  • Drug: IL-2
• 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.
  Interventions:

  • Drug: FT516
  • Drug: Rituximab
  • Drug: Obinutuzumab
  • Drug: IL-2
  • Drug: Bendamustine

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: July 15, 2019): 72
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 2039
• Estimated Primary Completion Date: May 2024 (Final data collection date for primary outcome measure)

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

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04023071
• Other Study ID Numbers: FT516-101
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Fate Therapeutics
• Original Responsible Party: Same as current
• Current Study Sponsor: Fate Therapeutics
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Fate Trial Disclosure; Fate Therapeutics

• PRS Account: Fate Therapeutics
• Verification Date: April 2023