Chronic Lymphocytic Leukemia Clinical Trial
Official title:
Phase I Trial of huCART19-IL18 Cells in Patients With Relapsed or Refractory CD19+ Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)
The purpose of this study is to find the maximum dose of huCART19-IL18 cells that is safe for use in humans with CD19+ cancers.
This is a Phase I dose finding study to determine the maximum tolerated dose (MTD) and assess the safety, tolerability, manufacturing feasibility, pharmacokinetics, and preliminary efficacy of huCART19-IL18 cells in patients with CD19+ cancers. Up to 7 total dose levels will be evaluated using the Bayesian Optimal Interval (BOIN) design with accelerated titration in order to determine the maximum tolerated dose (MTD) of huCART19-IL18 cells within each of the following disease-specific cohorts: - Cohort A: Non-Hodgkin Lymphoma (NHL) - Cohort B: Chronic Lymphocytic Leukemia (CLL) - Cohort C: Acute Lymphoblastic Leukemia (ALL) ;
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