FT516 in Subjects With Advanced Hematologic Malignancies

October 25, 2023 updated by: Fate Therapeutics

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic
    • California
      • San Diego, California, United States, 92037
        • UC San Diego
    • Colorado
      • Denver, Colorado, United States, 80045
        • University of Colorado, Denver
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Masonic Cancer Center
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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: Cyclophosphamide
Conditioning agent
Drug: Fludarabine
Conditioning agent
Drug: IL-2
Biologic response modifier
Drug: Rituximab
Monoclonal Antibody
Other Names:
  • Rituxan
  • MabThera
Drug: Obinutuzumab
Monoclonal Antibody
Other Names:
  • Gazyva
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: Cyclophosphamide
Conditioning agent
Drug: Fludarabine
Conditioning agent
Drug: IL-2
Biologic response modifier
Drug: Rituximab
Monoclonal Antibody
Other Names:
  • Rituxan
  • MabThera
Drug: Obinutuzumab
Monoclonal Antibody
Other Names:
  • Gazyva
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: IL-2
Biologic response modifier
Drug: Rituximab
Monoclonal Antibody
Other Names:
  • Rituxan
  • MabThera
Drug: Obinutuzumab
Monoclonal Antibody
Other Names:
  • Gazyva
Drug: Bendamustine
Conditioning agent
Other Names:
  • Treanda
  • Bendeka

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The incidence of subjects with Dose Limiting Toxicities within each dose level cohort.
Time Frame: Day 29
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
Up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fate Therapeutics

Investigators

  • Study Director: Fate Trial Disclosure, Fate Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2019

Primary Completion (Actual)

October 23, 2023

Study Completion (Actual)

October 23, 2023

Study Registration Dates

First Submitted

July 9, 2019

First Submitted That Met QC Criteria

July 15, 2019

First Posted (Actual)

July 17, 2019

Study Record Updates

Last Update Posted (Actual)

October 26, 2023

Last Update Submitted That Met QC Criteria

October 25, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FT516-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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