Description:
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 will consist of a dose-escalation stage and an expansion stage where participants will
be enrolled into indication-sepcific cohorts.
Title
- Brief Title: FT516 in Subjects With Advanced Hematologic Malignancies
- Official Title: 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
Clinical Trial IDs
- ORG STUDY ID:
FT516-101
- NCT ID:
NCT04023071
Conditions
- Acute Myelogenous Leukemia
- B-cell Lymphoma
Interventions
Drug | Synonyms | Arms |
---|
FT516 | | FT516 Monotherapy |
Rituximab | Rituxan, MabThera | FT516 in Combination with Monoclonal Antibodies |
Obinutuzumab | Gazyva | FT516 in Combination with Monoclonal Antibodies |
Cyclophosphamide | | FT516 Monotherapy |
Fludarabine | | FT516 Monotherapy |
IL-2 | | FT516 Monotherapy |
Purpose
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 will consist of a dose-escalation stage and an expansion stage where participants will
be enrolled into indication-sepcific cohorts.
Trial Arms
Name | Type | Description | Interventions |
---|
FT516 Monotherapy | Experimental | FT516 monotherapy in adult subjects with r/r AML. | - FT516
- Cyclophosphamide
- Fludarabine
- IL-2
|
FT516 in Combination with Monoclonal Antibodies | Experimental | FT516 in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab. | - FT516
- Rituximab
- Obinutuzumab
- Cyclophosphamide
- Fludarabine
- IL-2
|
Eligibility 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
- Provision of signed and dated ICF to agree to participate, at time of withdrawal or
completion of this study, in Fate Therapeutics' long-term follow-up study.
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
- QTc >450 msec on screening ECG
Additional Exclusion Criteria for Regimen A (FT516 monotherapy): Diagnosis of promyelocytic
leukemia with t(15:17) translocation
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | The incidence of subjects with Dose Limiting Toxicities within each dose level cohort. |
Time Frame: | Day 29 |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Incidence and nature of AEs of FT516 as monotherapy in r/r AML and in combination with rituximab or obinutuzumab in r/r B-cell lymphoma. |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Severity of AEs of FT516 as monotherapy in r/r AML and in combination with rituximab or obinutuzumab in r/r B-cell lymphoma. |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Objective response rate (ORR) of FT516 as monotherapy in r/r AML and in combination with rituximab or obinutuzumab in r/r B-cell lymphoma. |
Time Frame: | Cycle 2 Day 29 |
Safety Issue: | |
Description: | |
Measure: | FT516 pharmacokinetic data |
Time Frame: | Cycle 1 and Cycle 2 Study Days: 1, 4, 8, 11, 15, 18, 22, 29, and Cycle 2 Day 43 and Cycle 2 Day 57. |
Safety Issue: | |
Description: | Percentage of donor DNA measured at each timepoint |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Fate Therapeutics |
Trial Keywords
Last Updated
March 5, 2021