FT819 in Subjects With B-cell Malignancies
A Phase I Study of FT819 in Subjects With B-cell Malignancies
1 other identifier
interventional
54
1 country
18
Brief Summary
This is a Phase I dose-finding study of FT819 as monotherapy and in combination with IL-2 in subjects with relapsed/refractory B-cell Lymphoma, Chronic Lymphocytic Leukemia and Precursor B-cell Acute Lymphoblastic Leukemia. 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 Jul 2021
Longer than P75 for phase_1
18 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
First Submitted
Initial submission to the registry
November 10, 2020
CompletedFirst Posted
Study publicly available on registry
November 16, 2020
CompletedStudy Start
First participant enrolled
July 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 18, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2039
ExpectedMarch 19, 2026
March 1, 2026
3.9 years
November 10, 2020
March 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence and nature of dose-limiting toxicities within each dose level cohort
Up to Day 29
Incidence, nature, and severity of adverse events (AEs) of FT819 as monotherapy and in combination with IL-2 in r/r B-cell lymphoma, r/r chronic lymphocytic leukemia, and r/r precursor B-cell acute lymphoblastic leukemia
Up to 15 years
Secondary Outcomes (7)
Investigator-assessed objective-response rate (ORR)
Up to approximately 2 years after last dose of FT819
For BCL and CLL Only: Investigator-assessed duration of objective response (DOR)
Up to 15 years
For BCL and CLL Only: Investigator-assessed duration of complete response (DoCR)
Up to 15 years
For BCL and CLL Only: Progression-free survival (PFS)
Up to 15 years
Overall survival (OS)
Up to 15 years
- +2 more secondary outcomes
Study Arms (12)
FT819 Single-Dose Monotherapy, B-Cell Lymphoma
EXPERIMENTALFT819 single-dose monotherapy in adult subjects with r/r B-cell Lymphoma
FT819 Single-Dose in Combination with IL-2, B-Cell Lymphoma
EXPERIMENTALFT819 single-dose in combination with IL-2 in adult subjects with r/r B-cell Lymphoma
FT819 Step Fractionated Monotherapy, B-Cell Lymphoma
EXPERIMENTALFT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r B-cell Lymphoma
FT819 Single-Dose Monotherapy, CLL
EXPERIMENTALFT819 single-dose monotherapy in adult subjects with r/r CLL
FT819 Single-Dose in Combination with IL-2, CLL
EXPERIMENTALFT819 single-dose in combination with IL-2 in adult subjects with r/r CLL
FT819 Step Fractionated Monotherapy, CLL
EXPERIMENTALFT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r CLL
FT819 Single-Dose Monotherapy, B-ALL
EXPERIMENTALFT819 single-dose monotherapy in adult subjects with r/r B-ALL
FT819 Single-Dose in Combination with IL-2, B-ALL
EXPERIMENTALFT819 single-dose in combination with IL-2 in adult subjects with r/r B-ALL
FT819 Step Fractionated Monotherapy, B-ALL
EXPERIMENTALFT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r B-ALL
FT819 Step Fractionated Monotherapy in Combination with IL-2, B-Cell Lymphoma
EXPERIMENTALFT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r B-cell Lymphoma
FT819 Step Fractionated Monotherapy in Combination with IL-2, CLL
EXPERIMENTALFT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r CLL
FT819 Step Fractionated Monotherapy in Combination with IL-2, B-ALL
EXPERIMENTALFT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r B-ALL
Interventions
Experimental Interventional Therapy
Lympho-conditioning agent
Biologic response modifier
Lympho-conditioning agent
Lympho-conditioning agent
Eligibility Criteria
You may qualify if:
- Diagnosis of B-cell lymphoma, CLL or B-ALL as described below:
- B-Cell Lymphoma:
- Histologically documented lymphomas expected to express CD19
- Relapsed/refractory disease following at least 2 prior lines of multi-agent immunochemotherapy
- Chronic Lymphocytic Leukemia (CLL):
- Diagnosis of CLL per iwCLL guidelines
- Relapsed/refractory disease following at least two prior systemic treatment regimens
- Precursor B-cell Acute Lymphocytic Leukemia (B-ALL):
- Diagnosis of B-ALL by flow cytometry, bone marrow histology, and/or cytogenetics
- Relapsed/refractory disease after at least 2 cycles of standard multiagent induction chemotherapy. For subjects with Philadelphia-chromosome positive (Ph+) disease, failure or intolerance to a tyrosine kinase inhibitor therapy-containing regimen
- ALL SUBJECTS:
- Capable of giving signed informed consent
- Age ≥ 18 years old
- Stated willingness to comply with study procedures and duration
- Contraceptive use for women and men as defined in the protocol
You may not qualify if:
- ALL SUBJECTS:
- Females who are pregnant or breastfeeding
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≥2
- Body weight \<50 kg
- Evidence of insufficient organ function
- Receipt of therapy within 2 weeks prior to Day 1 or five half-lives, whichever is shorter; or any investigational therapy within 28 days prior to Day 1
- Currently receiving or likely to require systemic immunosuppressive therapy
- Ongoing requirement for systemic GvHD therapy following prior allogeneic hematopoietic stem cell transplant (HSCT) or allogeneic CAR-T
- Receipt of an allograft organ transplant
- Known active central nervous system (CNS) involvement by malignancy
- Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
- Clinically significant cardiovascular disease
- Positive serologic test results for HIV infection
- Positive serologic and polymerase chain reaction (PCR) test results for Hepatitis B (HBV) infection
- Positive serologic and PCR test results for Hepatitis C (HCV) infection
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Mayo Arizona
Phoenix, Arizona, 85054, United States
UC Davis
Davis, California, 95817, United States
Scripps Green Hospital
La Jolla, California, 92037, United States
UCLA Ronald Reagan Medical Center
Los Angeles, California, 90095, United States
Stanford Cancer Institute
Palo Alto, California, 94304, United States
University of Florida
Gainesville, Florida, 32608, United States
Mayo Florida
Jacksonville, Florida, 32224, United States
University of Iowa
Iowa City, Iowa, 52242, United States
The University of Kansas Cancer Center
Westwood, Kansas, 66205, United States
Norton Cancer Institute, St. Matthews Campus
Louisville, Kentucky, 40207, United States
Mayo Minnesota
Rochester, Minnesota, 55905, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10021, United States
Oregon Health & Sciences University
Portland, Oregon, 97239, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
University of Wisconsin-Madison
Madison, Wisconsin, 53705, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Fate Trial Disclosure
Fate Therapeutics
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2020
First Posted
November 16, 2020
Study Start
July 12, 2021
Primary Completion
June 18, 2025
Study Completion (Estimated)
September 30, 2039
Last Updated
March 19, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share