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出境医 / 临床实验 / FT516 in Subjects With Advanced Hematologic Malignancies

FT516 in Subjects With Advanced Hematologic Malignancies

Study Description
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

Study Design
Layout table for study information
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
Arms and Interventions
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
Outcome Measures
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


Eligibility Criteria
Layout table for eligibility information
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

Contacts and Locations

Contacts
Layout table for location contacts
Contact: Kelly Griffis 8588751800 clinical@fatetherapeutics.com
Contact: Jamuna Thimmarayappa 8588751800

Locations
Layout table for location information
United States, Arizona
Mayo Clinic Recruiting
Phoenix, Arizona, United States, 85054
United States, California
UC San Diego Recruiting
San Diego, California, United States, 92037
United States, Minnesota
University of Minnesota Masonic Cancer Center Recruiting
Minneapolis, Minnesota, United States, 55455
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
United States, Washington
Swedish Cancer Institute Recruiting
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Fate Therapeutics
Investigators
Layout table for investigator information
Study Director: Rebecca Elstrom, MD Fate Therapeutics
Tracking Information
First Submitted Date  ICMJE July 9, 2019
First Posted Date  ICMJE July 17, 2019
Last Update Posted Date March 5, 2021
Actual Study Start Date  ICMJE October 4, 2019
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2019) 		The incidence of subjects with Dose Limiting Toxicities within each dose level cohort. [ Time Frame: Day 29 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE FT516 in Subjects With Advanced Hematologic Malignancies
Official Title  ICMJE 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 will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-sepcific cohorts.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Myelogenous Leukemia
  • B-cell Lymphoma
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 15, 2019) 		72
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2026
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kelly Griffis 8588751800 clinical@fatetherapeutics.com
Contact: Jamuna Thimmarayappa 8588751800
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04023071
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Responsible Party Fate Therapeutics
Study Sponsor  ICMJE Fate Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Rebecca Elstrom, MD Fate Therapeutics
PRS Account Fate Therapeutics
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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