To determine the safety, toxicity, and maximum tolerated dose (MTD) of CD19/CD20 bispecific CAR-T cells with 4-1BB and mutated CD28 costimulatory domains (20-19 Tan BB06z) in patients with relapsed or refractory CD19+ aggressive hematologic malignancies
The purpose of this study is to test the safety of 20-19 Tan BB06z CAR T cells in people with different types of relapsed/refractory CD19-positive blood cancer. Different doses of 20-19 Tan BB06z CAR T cells will be tested to find the highest dose that causes few or mild side effects in participants
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
This investigational product is a genetically modified chimeric antigen receptor t-cell product expressing a biospecific anti CD19/CD20 and incorporating both 4-1BB and mutated CD28 costimulatory domains.
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
Maximum Tolerated Dose (MDT)
MTD will be established from Dose limiting toxicities after infusion
Time frame: up to 2 years
Event Free Survival
Time from Car-T cell infusion to disease progression, relapse or death from anycause,w hichever occured first. EFS will be assessed by using the Kaplan-Meier method.
Time frame: UP to 2 years
Overall Survival
Date of infusion until death. OS will be assessed using the Kaplan-Meier method
Time frame: Up to 2 years
persistence of modified T-cells
Duration of T-cell persistence will be estimated using flow cytometry in peripheral blood and bone marrow.
Time frame: Up to 2 years
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