Large B-cell Lymphoma Clinical Trial
Official title:
A Phase I Clinical Study of CD19-targeted Chimeric Antigen Receptor (CAR) T Cells Injection, for Relapsed and Refractory (R/R) Large B-cell Lymphoma
This is an open-label, multicenter, dose-escalation phase 1 study to determine the Safety and Efficacy of BZ019 in relapsed or refractory CD19+ B-cell Lymphoma subjects.
This is an open-label, multicenter, phase 1 study to determine the safety, PK, and antitumor
activity of BZ019 in adult subjects with R/R large CD19+B cell lymphoma. The safety and
efficacy of a single dose of different target doses of BZ019 will be evaluated in the
dose-escalation phase and dose-expansion phase.
Primary objectives:
- To evaluate the safety and tolerance of single infusion of BZ019 in adult patients with
relapsed or refractory large B-cell lymphoma, and to determine the maximum tolerable dose
(MTD) and phase II recommended dose.
Secondary objectives：
- To evaluate the pharmacokinetics and survival of BZ019 in the peripheral blood of adult
patients with relapsed or refractory large B-cell lymphoma;
- To evaluate the Pharmacodynamic characteristics of BZ019 in adult patients with relapsed
or refractory large B-cell lymphoma;
- Objective response rate (ORR), Overall survival, progression free survival, event free
survival, and tumor progression time were used to evaluate the antitumor efficacy of
BZ019 in the treatment of relapsed or refractory large B-cell lymphoma.
;
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