This is a Phase I dose-finding study of FT596 as monotherapy and in combination with Rituximab or Obinutuzumab in subjects with relapsed/refractory B-cell Lymphoma or Chronic Lymphocytic 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
98
Experimental Interventional Therapy
Lympho-conditioning agent
Lympho-conditioning agent
The University of Chicago
Chicago, Illinois, United States
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Incidence of dose-limiting toxicities within each dose level cohort
Time frame: Day 29
Nature of dose-limiting toxicities within each dose level cohort
Time frame: Day 29
Incidence, nature, and severity of adverse events (AEs) of FT596 as monotherapy and in combination with rituximab or obinutuzumab in r/r B-cell lymphomas and r/r chronic lymphocytic leukemia, with severity determined according to NCI CTCAE, v5.0
Time frame: Up to 15 years
Investigator-assessed objective-response rate (ORR)
Proportion of subjects who achieve a partial response (PR) or complete response (CR) per Lugano 2014 classification for lymphomas, a partial remission (PR) or complete remission (CR) per revised iwCLL guidelines for CLL.
Time frame: From baseline tumor assessment up to approximately 2 years after last dose of FT596
Investigator-assessed duration of objective response (DOR)
Defined as the duration from the first occurrence of a documented objective response (DOR) until the time of disease progression or relapse, or death from any cause, whichever occurs first, per Lugano 2014 classification for lymphomas or revised iwCLL guidelines for CLL.
Time frame: Up to 15 years
Investigator-assessed duration of complete response (DoCR)
Defined as the duration from the first occurrence of a documented complete response (CR) per Lugano 2014 classification for lymphomas or complete remission (CR) per revised iwCLL guidelines for CLL, until the time of disease progression or relapse, or death from any cause, whichever occurs first.
Time frame: Up to 15 years
Progression-free survival (PFS)
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Monoclonal Antibody
Monoclonal Antibody
Conditioning agent
NYU Langone Health
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Sarah Cannon Research Institute (Tennessee Oncology)
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
SCRI-TTI
San Antonio, Texas, United States
Swedish Cancer Institute
Seattle, Washington, United States
Defined as the time from from first dose of lympho-conditioning to progressive disease (PD), or to the day of death for any reason, whichever occurs earlier, based on Lugano 2014 classification for lymphomas or revised iwCLL guidelines for CLL
Time frame: Up to 15 years
Overall survival (OS), defined as the time from first dose of lympho-conditioning to death from any cause.
Time frame: Up to 15 years
The pharmacokinetics of FT596 in peripheral blood will be reported as the relative percentage of product (FT596) DNA versus patient DNA (% chimerism) measured from blood samples at the specified time points
Time frame: Study Days: 1, 2, 4, 8, 11, 15, 18, 22, 29