Acute Myeloid Leukemia Clinical Trial
FT516 in Subjects With Advanced Hematologic Malignancies
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.
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.
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:
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
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There are 7 Locations for this study
Phoenix Arizona, 85054, United States
San Diego California, 92037, United States
Denver Colorado, 80045, United States
Minneapolis Minnesota, 55455, United States
Dallas Texas, 75390, United States
Houston Texas, 77030, United States
Seattle Washington, 98104, United States
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