Roswell Park Cancer Institute
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
Inclusion Criteria: * To be eligible for leukapheresis, patients must have an aggressive CD19+ B cell malignancy with relapsed or refractory disease, defined as below. * To be eligible for treatment with 20-19 Tan BB06z CAR-T cells, patients must additionally have detectable evidence of residual malignancy at the time of assessment prior to CAR-T cell infusion, regardless of therapy administered following leukapheresis. To be included in this study, participants must meet the following criteria: 1\. Patients with R/R B-Cell malignancies (see below) which commonly express CD19 and CD20. Elig…
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.
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