Clinical trial NCT04023071: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Acute Myelogenous Leukemia
B-cell Lymphoma
Keywords: AML
Lymphoma
Lead sponsor: Fate Therapeutics
Sponsor class: INDUSTRY
First posted: 2019-07-17
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

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

Primary outcomes:
measure: The incidence of subjects with Dose Limiting Toxicities within each dose level cohort.
timeFrame: Day 29
measure: 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.
timeFrame: Up to 5 years
Secondary outcomes:
measure: 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.
timeFrame: Cycle 2 Day 29
measure: FT516 pharmacokinetic data
timeFrame: 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.
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
city: San Diego
country: United States
facility: UC San Diego
state: California
city: Denver
country: United States
facility: University of Colorado, Denver
state: Colorado
city: Minneapolis
country: United States
facility: University of Minnesota Masonic Cancer Center
state: Minnesota
city: Dallas
country: United States
facility: UT Southwestern
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
Study officials:
affiliation: Fate Therapeutics
name: Fate Trial Disclosure
role: STUDY_DIRECTOR
References: