Status:
TERMINATED
FT516 in Subjects With Advanced Hematologic Malignancies
Lead Sponsor:
Fate Therapeutics
Conditions:
Acute Myelogenous Leukemia
B-cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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 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
Exclusion
Key Trial Info
Start Date :
October 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 23 2023
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04023071
Start Date
October 4 2019
End Date
October 23 2023
Last Update
October 26 2023
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic
Phoenix, Arizona, United States, 85054
2
UC San Diego
San Diego, California, United States, 92037
3
University of Colorado, Denver
Denver, Colorado, United States, 80045
4
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, United States, 55455