Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Fate Therapeutics
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
