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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04023071
Recruitment Status : Recruiting
First Posted : July 17, 2019
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
Fate Therapeutics

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

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 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 2021
Estimated Study Completion Date : May 2026


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

Drug: Cyclophosphamide
Lympho-conditioning agent

Drug: Fludarabine
Lympho-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
Lympho-conditioning agent

Drug: Fludarabine
Lympho-conditioning agent

Drug: IL-2
Biologic response modifier




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

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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



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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
  • 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


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


Contacts
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Contact: Kelly Griffis 8588751800 clinical@fatetherapeutics.com
Contact: Sara Weymer 8588751800

Locations
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United States, Minnesota
University of Minnesota Masonic Cancer Center Recruiting
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Fate Therapeutics
Investigators
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Study Director: Wayne Chu, MD Fate Therapeutics

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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: January 9, 2020
Last Verified: October 2019
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
Rituximab
Fludarabine
Obinutuzumab
Antineoplastic Agents, Immunological
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists