FT516 in Subjects With Advanced Hematologic Malignancies
NCT ID: NCT04023071
Last Updated: 2023-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
72 participants
INTERVENTIONAL
2019-10-04
2023-10-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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FT516 Monotherapy
FT516 monotherapy in adult subjects with r/r AML.
FT516
Experimental Interventional Therapy
Cyclophosphamide
Conditioning agent
Fludarabine
Conditioning agent
IL-2
Biologic response modifier
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.
FT516
Experimental Interventional Therapy
Rituximab
Monoclonal Antibody
Obinutuzumab
Monoclonal Antibody
Cyclophosphamide
Conditioning agent
Fludarabine
Conditioning agent
IL-2
Biologic response modifier
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.
FT516
Experimental Interventional Therapy
Rituximab
Monoclonal Antibody
Obinutuzumab
Monoclonal Antibody
Cyclophosphamide
Conditioning agent
Fludarabine
Conditioning agent
IL-2
Biologic response modifier
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.
FT516
Experimental Interventional Therapy
Rituximab
Monoclonal Antibody
Obinutuzumab
Monoclonal Antibody
IL-2
Biologic response modifier
Bendamustine
Conditioning agent
Interventions
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FT516
Experimental Interventional Therapy
Rituximab
Monoclonal Antibody
Obinutuzumab
Monoclonal Antibody
Cyclophosphamide
Conditioning agent
Fludarabine
Conditioning agent
IL-2
Biologic response modifier
Bendamustine
Conditioning agent
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Fate Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Fate Trial Disclosure
Role: STUDY_DIRECTOR
Fate Therapeutics
Locations
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Mayo Clinic
Phoenix, Arizona, United States
UC San Diego
San Diego, California, United States
University of Colorado, Denver
Denver, Colorado, United States
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, United States
UT Southwestern
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Swedish Cancer Institute
Seattle, Washington, United States
Countries
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References
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Strati P, Castro J, Goodman A, Bachanova V, Kamdar M, Awan FT, Solomon SR, Wong L, Wong C, Patel D, Bickers C, Zhao W, Bashir Z, Valamehr B, Elstrom RL, Patel K. Off-the-shelf induced pluripotent stem-cell-derived natural killer-cell therapy in relapsed or refractory B-cell lymphoma: a multicentre, open-label, phase 1 study. Lancet Haematol. 2025 Jul;12(7):e505-e515. doi: 10.1016/S2352-3026(25)00142-5.
Other Identifiers
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FT516-101
Identifier Type: -
Identifier Source: org_study_id
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