Diffuse Large B Cell Lymphoma Clinical Trial
Official title:
A Single Cohort, Open-label, Multicenter, Dose-escalation Study of Safety and Efficacy of BZ019 for Adult CD19 Positive Relapsed and Refractory B-cell Non-Hodgkin 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.
This is an open-label, multicenter, phase 1 study to determine the safety and antitumor
activity of BZ019 in adult patients with R/R large B cell lymphoma (DLBCL),including: DLBCL,
not otherwise specified (NOS), transformed DLBCL, high-grade B-cell lymphoma with MYC and
BCL2 and/or BCL6 rearrangements and primary mediastinal B-cell lymphoma (PMBCL).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.
Upon enrollment, subjects will undergo leukapheresis to enable BZ019 product generation. A
baseline tumor biopsy (in subjects with accessible disease) and bone marrow aspirate and
biopsy will be obtained.
Upon successful BZ019 product generation, subjects will enter the treatment phase and receive
BZ019 infusion. A completed treatment program will include lymphodepleting chemotherapy with
fludarabine and cyclophosphamide (flu/cy) followed by single-dose of BZ019 infusion. BZ019
will be administered 2 to 14 days after the completion of lymphodepleting chemotherapy.
After the infusion of BZ019, subjects will be in the follow-up period upon 12 months for
evaluation the safety and efficacy of BZ019. Subjects will be followed for long-term safety,
overall survival even after disease progression.
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