Study Stopped
This study was terminated by the Sponsor.
FT538 in Subjects With Advanced Hematologic Malignancies
A Phase I, Open-Label, Multicenter Study of FT538 as Monotherapy in Relapsed/Refractory Acute Myelogenous Leukemia and in Combination With Monoclonal Antibodies in Relapsed/Refractory Multiple Myeloma
1 other identifier
interventional
42
1 country
8
Brief Summary
This is a Phase I dose-finding study of FT538 as monotherapy in acute myeloid leukemia (AML) and in combination with monoclonal antibodies in multiple myeloma (MM). The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Oct 2020
Typical duration for phase_1
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 17, 2020
CompletedFirst Submitted
Initial submission to the registry
October 29, 2020
CompletedFirst Posted
Study publicly available on registry
November 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 13, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 8, 2023
CompletedSeptember 21, 2023
September 1, 2023
2.7 years
October 29, 2020
September 19, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of dose-limiting toxicities (DLTs) within each dose level cohort
Cycle 1, Up to Day 29
Nature of dose-limiting toxicities within each dose level cohort
Cycle 1, Up to Day 29
Secondary Outcomes (9)
Incidence, nature, and severity of adverse events (AEs) of FT538 as monotherapy in r/r AML and in combination with daratumumab or elotuzumab in r/r multiple myeloma
Up to 5 years
Objective response rate (ORR) of FT538 as monotherapy in r/r AML and in combination with daratumumab or elotuzumab in r/r MM
From baseline tumor assessment up to approximately 2 years after last dose of FT538
Duration of response (DOR) of FT538 in combination with daratumumab or elotuzumab in r/r MM
Up to 15 years
Progression-free survival (PFS) of FT538 in combination with daratumumab or elotuzumab in r/r MM
Up to 15 years
Relapse-free survival (RFS) of FT538 as monotherapy in r/r AML and in combination with daratumumab or elotuzumab in r/r MM
Up to 15 years
- +4 more secondary outcomes
Study Arms (3)
FT538 Monotherapy
EXPERIMENTALFT538 monotherapy in subjects with r/r AML
FT538 in Combination with Daratumumab
EXPERIMENTALFT538 in combination with daratumumab in subjects with r/r MM
FT538 in Combination with Elotuzumab
EXPERIMENTALFT538 in combination with elotuzumab in subjects with r/r MM
Interventions
Experimental Interventional Therapy, Allogeneic Cell Therapy NK Cell
Lympho-conditioning Agent
Lympho-conditioning Agent
Monoclonal Antibody, CD38, Anti-CD38
Eligibility Criteria
You may qualify if:
- Diagnosis of one of the following by treatment regimen:
- Regimen A (FT538 monotherapy in r/r AML)
- Primary refractory AML, or
- Relapsed AML, defined as not in CR after one or more re-induction attempts; if \>60 years of age, prior re-induction therapy is not required
- Regimens B or C (FT538 + mAb in r/r MM)
- Regimen B only: MM that has relapsed or progressed after at least two lines of therapies, including a proteasome inhibitor and an immunomodulatory drug
- Regimen C only: MM that has relapsed or progressed after proteasome inhibitor therapy, and immunomodulatory therapy
- Regimen B and Regimen C: Measurable disease as defined in the protocol
- Capable of giving signed informed consent
- Agreement to comply with study procedures as described in the Schedule of Activities
- Agrees to contraceptive use as described in the protocol
You may not qualify if:
- Females who are pregnant or breastfeeding
- ECOG Performance Status ≥ 2
- Evidence of insufficient hematologic function as defined in the protocol
- Evidence of insufficient organ function defined as defined by the protocol
- Clinically significant cardiovascular disease as defined by the protocol
- Known active central nervous system (CNS) involvement by malignancy
- Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease or receipt of medications for these conditions in the 2-year period leading up to study enrollment
- Currently receiving or likely to require systemic immunosuppressive therapy for any reason during the treatment period
- Clinically significant infections including HIV, HBV and HCV
- Live vaccine \<6 weeks prior to start of lympho-conditioning
- Receipt of an allograft organ transplant
- Prior allogeneic HSCT or allogeneic CAR-T within 6 months of Day 1, or ongoing requirement for systemic graft-versus-host therapy
- Known allergy to albumin (human) or DMSO
- Presence of any medical or social issues that are likely to interfere with study conduct or may cause increased risk to subject
- Any medical condition or clinical laboratory abnormality that per investigator or Medical Monitor judgement precludes safe participation in and completion of the study, or which could affect compliance with protocol conduct or interpretation of results
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, 55455, United States
Washington University
St Louis, Missouri, 63110, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Sarah Cannon Research Institute at Tennessee Oncology
Nashville, Tennessee, 37203, United States
St. David's South Austin Medical Center
Austin, Texas, 78704, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Texas Transplant Institute
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Fate Trial Disclosure
Fate Therapeutics, Inc
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2020
First Posted
November 4, 2020
Study Start
October 17, 2020
Primary Completion
July 13, 2023
Study Completion
August 8, 2023
Last Updated
September 21, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share