Study Stopped
The study was terminated by the Sponsor.
FT516 in Subjects With Advanced Hematologic Malignancies
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
1 other identifier
interventional
72
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2019
Longer than P75 for phase_1
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2019
CompletedFirst Posted
Study publicly available on registry
July 17, 2019
CompletedStudy Start
First participant enrolled
October 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 23, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 23, 2023
CompletedOctober 26, 2023
October 1, 2023
4.1 years
July 9, 2019
October 25, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The incidence of subjects with Dose Limiting Toxicities within each dose level cohort.
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.
Up to 5 years
Secondary Outcomes (2)
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.
Cycle 2 Day 29
FT516 pharmacokinetic data
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.
Study Arms (4)
FT516 Monotherapy
EXPERIMENTALFT516 monotherapy in adult subjects with r/r AML.
FT516 in Combination with Monoclonal Antibodies
EXPERIMENTALFT516 in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab.
FT516 in Combination with Monoclonal Antibodies on an Extended-Dosing Schedule
EXPERIMENTALFT516 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 in Combination with Monoclonal Antibodies following Bendamustine Conditioning
EXPERIMENTALBendamustine 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.
Interventions
Experimental Interventional Therapy
Monoclonal Antibody
Monoclonal Antibody
Conditioning agent
Conditioning agent
Biologic response modifier
Conditioning agent
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Mayo Clinic
Phoenix, Arizona, 85054, United States
UC San Diego
San Diego, California, 92037, United States
University of Colorado, Denver
Denver, Colorado, 80045, United States
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, 55455, United States
UT Southwestern
Dallas, Texas, 75390, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Swedish Cancer Institute
Seattle, Washington, 98104, United States
Related Publications (1)
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.
PMID: 40610174DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Fate Trial Disclosure
Fate Therapeutics
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2019
First Posted
July 17, 2019
Study Start
October 4, 2019
Primary Completion
October 23, 2023
Study Completion
October 23, 2023
Last Updated
October 26, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share