FT819 in Subjects With B-cell Malignancies
Phase 1
Active, not recruiting
- Conditions
- Chronic Lymphocytic LeukemiaLymphoma, B-CellPrecursor B-Cell Acute Lymphoblastic Leukemia
- Interventions
- Registration Number
- NCT04629729
- Lead Sponsor
- Fate Therapeutics
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 54
Inclusion Criteria
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
Key
Exclusion Criteria
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
- Live vaccine <6 weeks prior to start of lympho-conditioning
- Known allergy to albumin (human) or DMSO
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description FT819 Single-Dose in Combination with IL-2, B-ALL IL-2 FT819 single-dose in combination with IL-2 in adult subjects with r/r B-ALL FT819 Single-Dose Monotherapy, B-Cell Lymphoma FT819 FT819 single-dose monotherapy in adult subjects with r/r B-cell Lymphoma FT819 Single-Dose Monotherapy, B-Cell Lymphoma Cyclophosphamide FT819 single-dose monotherapy in adult subjects with r/r B-cell Lymphoma FT819 Single-Dose Monotherapy, B-Cell Lymphoma Fludarabine FT819 single-dose monotherapy in adult subjects with r/r B-cell Lymphoma FT819 Single-Dose Monotherapy, B-Cell Lymphoma Bendamustine FT819 single-dose monotherapy in adult subjects with r/r B-cell Lymphoma FT819 Single-Dose in Combination with IL-2, B-Cell Lymphoma FT819 FT819 single-dose in combination with IL-2 in adult subjects with r/r B-cell Lymphoma FT819 Single-Dose in Combination with IL-2, B-Cell Lymphoma Cyclophosphamide FT819 single-dose in combination with IL-2 in adult subjects with r/r B-cell Lymphoma FT819 Single-Dose in Combination with IL-2, B-Cell Lymphoma Fludarabine FT819 single-dose in combination with IL-2 in adult subjects with r/r B-cell Lymphoma FT819 Step Fractionated Monotherapy in Combination with IL-2, B-ALL Fludarabine FT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r B-ALL FT819 Step Fractionated Monotherapy in Combination with IL-2, B-ALL IL-2 FT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r B-ALL FT819 Step Fractionated Monotherapy in Combination with IL-2, B-ALL Bendamustine FT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r B-ALL FT819 Single-Dose in Combination with IL-2, B-Cell Lymphoma Bendamustine FT819 single-dose in combination with IL-2 in adult subjects with r/r B-cell Lymphoma FT819 Step Fractionated Monotherapy, B-Cell Lymphoma FT819 FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r B-cell Lymphoma FT819 Step Fractionated Monotherapy, B-Cell Lymphoma Fludarabine FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r B-cell Lymphoma FT819 Single-Dose Monotherapy, CLL FT819 FT819 single-dose monotherapy in adult subjects with r/r CLL FT819 Single-Dose Monotherapy, CLL Cyclophosphamide FT819 single-dose monotherapy in adult subjects with r/r CLL FT819 Single-Dose Monotherapy, CLL Fludarabine FT819 single-dose monotherapy in adult subjects with r/r CLL FT819 Single-Dose in Combination with IL-2, CLL Bendamustine FT819 single-dose in combination with IL-2 in adult subjects with r/r CLL FT819 Single-Dose Monotherapy, CLL Bendamustine FT819 single-dose monotherapy in adult subjects with r/r CLL FT819 Single-Dose in Combination with IL-2, CLL FT819 FT819 single-dose in combination with IL-2 in adult subjects with r/r CLL FT819 Single-Dose in Combination with IL-2, CLL IL-2 FT819 single-dose in combination with IL-2 in adult subjects with r/r CLL FT819 Step Fractionated Monotherapy, CLL FT819 FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r CLL FT819 Step Fractionated Monotherapy, CLL Bendamustine FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r CLL FT819 Single-Dose Monotherapy, B-ALL FT819 FT819 single-dose monotherapy in adult subjects with r/r B-ALL FT819 Single-Dose Monotherapy, B-ALL Cyclophosphamide FT819 single-dose monotherapy in adult subjects with r/r B-ALL FT819 Step Fractionated Monotherapy, CLL Cyclophosphamide FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r CLL FT819 Step Fractionated Monotherapy, CLL Fludarabine FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r CLL FT819 Single-Dose in Combination with IL-2, B-ALL FT819 FT819 single-dose in combination with IL-2 in adult subjects with r/r B-ALL FT819 Step Fractionated Monotherapy, B-ALL FT819 FT819 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 FT819 FT819 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 FT819 FT819 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 FT819 FT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r B-ALL FT819 Single-Dose in Combination with IL-2, B-Cell Lymphoma IL-2 FT819 single-dose in combination with IL-2 in adult subjects with r/r B-cell Lymphoma FT819 Step Fractionated Monotherapy, B-Cell Lymphoma Cyclophosphamide FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r B-cell Lymphoma FT819 Step Fractionated Monotherapy, B-Cell Lymphoma Bendamustine FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r B-cell Lymphoma FT819 Single-Dose in Combination with IL-2, CLL Cyclophosphamide FT819 single-dose in combination with IL-2 in adult subjects with r/r CLL FT819 Single-Dose in Combination with IL-2, CLL Fludarabine FT819 single-dose in combination with IL-2 in adult subjects with r/r CLL FT819 Single-Dose Monotherapy, B-ALL Fludarabine FT819 single-dose monotherapy in adult subjects with r/r B-ALL FT819 Single-Dose Monotherapy, B-ALL Bendamustine FT819 single-dose monotherapy in adult subjects with r/r B-ALL FT819 Single-Dose in Combination with IL-2, B-ALL Cyclophosphamide FT819 single-dose in combination with IL-2 in adult subjects with r/r B-ALL FT819 Single-Dose in Combination with IL-2, B-ALL Fludarabine FT819 single-dose in combination with IL-2 in adult subjects with r/r B-ALL FT819 Single-Dose in Combination with IL-2, B-ALL Bendamustine FT819 single-dose in combination with IL-2 in adult subjects with r/r B-ALL FT819 Step Fractionated Monotherapy, B-ALL Cyclophosphamide FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r B-ALL FT819 Step Fractionated Monotherapy, B-ALL Fludarabine FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r B-ALL FT819 Step Fractionated Monotherapy, B-ALL Bendamustine FT819 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 Cyclophosphamide FT819 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, B-Cell Lymphoma Bendamustine FT819 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, B-Cell Lymphoma IL-2 FT819 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, B-Cell Lymphoma Fludarabine FT819 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 Cyclophosphamide FT819 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, CLL Fludarabine FT819 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, CLL IL-2 FT819 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, CLL Bendamustine FT819 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 Cyclophosphamide FT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r B-ALL
- Primary Outcome Measures
Name Time Method 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 Incidence and nature of dose-limiting toxicities within each dose level cohort Up to Day 29
- Secondary Outcome Measures
Name Time Method Overall survival (OS) Up to 15 years Investigator-assessed objective-response rate (ORR) Up to approximately 2 years after last dose of FT819 For B-ALL Only: Investigator-assessed relapse-free survival (RFS) Up to 15 years Determination of the pharmacokinetics of FT819 cells in peripheral blood. Study Days 1, 2, 3, 4, 5, 8, 11, 15, 22, and 29 The PK of FT819 in peripheral blood will be reported as the relative percentage of product (FT819) DNA versus patient DNA (% chimerism) measured from blood samples at the specified time points
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
Trial Locations
- Locations (17)
University of Iowa
🇺🇸Iowa City, Iowa, United States
Stanford Cancer Institute
🇺🇸Palo Alto, California, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Scripps Green Hospital
🇺🇸La Jolla, California, United States
UC Davis
🇺🇸Davis, California, United States
Mayo Florida
🇺🇸Jacksonville, Florida, United States
UCLA Ronald Reagan Medical Center
🇺🇸Los Angeles, California, United States
The University of Kansas Cancer Center
🇺🇸Westwood, Kansas, United States
University of Wisconsin-Madison
🇺🇸Madison, Wisconsin, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Oregon Health & Sciences University
🇺🇸Portland, Oregon, United States
Mayo Arizona
🇺🇸Phoenix, Arizona, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Mayo Minnesota
🇺🇸Rochester, Minnesota, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Norton Cancer Institute, St. Matthews Campus
🇺🇸Louisville, Kentucky, United States