Back to resultsFT516 in Subjects With Advanced Hematologic Malignancies
Primary Purpose
Acute Myelogenous Leukemia, B-cell Lymphoma
Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
FT516
Rituximab
Obinutuzumab
Cyclophosphamide
Fludarabine
IL-2
Bendamustine
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myelogenous Leukemia focused on measuring AML, Lymphoma
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
Sites / Locations
- Mayo Clinic
- UC San Diego
- University of Colorado, Denver
- University of Minnesota Masonic Cancer Center
- UT Southwestern
- MD Anderson Cancer Center
- Swedish Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
FT516 Monotherapy
FT516 in Combination with Monoclonal Antibodies
FT516 in Combination with Monoclonal Antibodies on an Extended-Dosing Schedule
FT516 in Combination with Monoclonal Antibodies following Bendamustine Conditioning
Arm Description
FT516 monotherapy in adult subjects with r/r AML.
FT516 in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab.
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.
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.
Outcomes
Primary Outcome Measures
The incidence of subjects with Dose Limiting Toxicities within each dose level cohort.
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.
Secondary Outcome Measures
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.
FT516 pharmacokinetic data
Percentage of donor DNA measured at each timepoint
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04023071
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 4, 2019 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2039 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fate Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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 includes three stages: dose escalation, safety confirmation, and dose expansion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myelogenous Leukemia, B-cell Lymphoma
Keywords
AML, Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FT516 Monotherapy
Arm Type
Experimental
Arm Description
FT516 monotherapy in adult subjects with r/r AML.
Arm Title
FT516 in Combination with Monoclonal Antibodies
Arm Type
Experimental
Arm Description
FT516 in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab.
Arm Title
FT516 in Combination with Monoclonal Antibodies on an Extended-Dosing Schedule
Arm Type
Experimental
Arm Description
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.
Arm Title
FT516 in Combination with Monoclonal Antibodies following Bendamustine Conditioning
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
FT516
Intervention Description
Experimental Interventional Therapy
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Rituxan, MabThera
Intervention Description
Monoclonal Antibody
Intervention Type
Drug
Intervention Name(s)
Obinutuzumab
Other Intervention Name(s)
Gazyva
Intervention Description
Monoclonal Antibody
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Conditioning agent
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Intervention Description
Conditioning agent
Intervention Type
Drug
Intervention Name(s)
IL-2
Intervention Description
Biologic response modifier
Intervention Type
Drug
Intervention Name(s)
Bendamustine
Other Intervention Name(s)
Bendeka, Treanda
Intervention Description
Conditioning agent
Primary Outcome Measure Information:
Title
The incidence of subjects with Dose Limiting Toxicities within each dose level cohort.
Time Frame
Day 29
Title
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
Secondary Outcome Measure Information:
Title
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
Title
FT516 pharmacokinetic data
Description
Percentage of donor DNA measured at each timepoint
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fate Trial Disclosure
Organizational Affiliation
Fate Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
UC San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
University of Colorado, Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Minnesota Masonic Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
UT Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Swedish Cancer Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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FT516 in Subjects With Advanced Hematologic Malignancies
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