Acute Myelogenous Leukemia, B-cell Lymphoma
Conditions
Keywords
AML, Lymphoma
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.
Interventions
DRUGFT516
Experimental Interventional Therapy
DRUGRituximab
Monoclonal Antibody
DRUGObinutuzumab
Monoclonal Antibody
DRUGCyclophosphamide
Conditioning agent
DRUGFludarabine
Conditioning agent
DRUGIL-2
Biologic response modifier
DRUGBendamustine
Conditioning agent
Sponsors
Fate Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| The incidence of subjects with Dose Limiting Toxicities within each dose level cohort. | Day 29 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Percentage of donor DNA measured at each timepoint |
Countries
United States
Outcome results
None listed