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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Experimental Interventional Therapy
Lympho-conditioning agent
Lympho-conditioning agent
University of Alabama at Birmingham
Birmingham, Alabama, United States
Mayo Arizona
Phoenix, Arizona, United States
Incidence and nature of dose-limiting toxicities within each dose level cohort
Time frame: 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
Time frame: Up to 15 years
Investigator-assessed objective-response rate (ORR)
Time frame: Up to approximately 2 years after last dose of FT819
For BCL and CLL Only: Investigator-assessed duration of objective response (DOR)
Time frame: Up to 15 years
For BCL and CLL Only: Investigator-assessed duration of complete response (DoCR)
Time frame: Up to 15 years
For BCL and CLL Only: Progression-free survival (PFS)
Time frame: Up to 15 years
Overall survival (OS)
Time frame: Up to 15 years
Determination of the pharmacokinetics of FT819 cells in peripheral blood.
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
Time frame: Study Days 1, 2, 3, 4, 5, 8, 11, 15, 22, and 29
For B-ALL Only: Investigator-assessed relapse-free survival (RFS)
Time frame: Up to 15 years
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Biologic response modifier
Lympho-conditioning agent
UC Davis
Davis, California, United States
Scripps Green Hospital
La Jolla, California, United States
UCLA Ronald Reagan Medical Center
Los Angeles, California, United States
Stanford Cancer Institute
Palo Alto, California, United States
Mayo Florida
Jacksonville, Florida, United States
University of Iowa
Iowa City, Iowa, United States
The University of Kansas Cancer Center
Westwood, Kansas, United States
Norton Cancer Institute, St. Matthews Campus
Louisville, Kentucky, United States
...and 7 more locations