FT516 in Subjects With Advanced Hematologic Malignancies

Acute Myelogenous Leukemia Clinical Trial

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 Details — Status: Terminated

Administrative data

• NCT number: NCT04023071
• Other study ID #: FT516-101
• Status: Terminated
• Phase: Phase 1
• Start date: October 4, 2019
• Est. completion date: October 23, 2023

Study information

• Verified date: October 2023
• Source: Fate Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 72
• Est. completion date: October 23, 2023
• Est. primary completion date: October 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myelogenous Leukemia
• B-cell Lymphoma
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Lymphoma
• Lymphoma, B-Cell

Intervention

Drug:
• FT516
Experimental Interventional Therapy
• Rituximab
Monoclonal Antibody
• Obinutuzumab
Monoclonal Antibody
• Cyclophosphamide
Conditioning agent
• Fludarabine
Conditioning agent
• IL-2
Biologic response modifier
• Bendamustine
Conditioning agent

Locations

Country	Name	City	State
United States	UT Southwestern	Dallas	Texas
United States	University of Colorado, Denver	Denver	Colorado
United States	MD Anderson Cancer Center	Houston	Texas
United States	University of Minnesota Masonic Cancer Center	Minneapolis	Minnesota
United States	Mayo Clinic	Phoenix	Arizona
United States	UC San Diego	San Diego	California
United States	Swedish Cancer Institute	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Fate Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of subjects with Dose Limiting Toxicities within each dose level cohort.		Day 29
Primary	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
Secondary	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
Secondary	FT516 pharmacokinetic data	Percentage of donor DNA measured at each timepoint	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.