NCT04067414

Exploratory Study of CD19-targeted Chimeric Antigen Receptor T Cells(BZ019) for Relapsed and Refractory B-cell Lymphoma

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Diffuse Large B Cell Lymphoma
• High-grade B-cell Lymphoma
• Transformed Lymphoma
• Primary Mediastinal Large B Cell Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	BZ019	Subjects will be enrolled in three dose-groups: Dose 1: 1×10\^6/kg CAR+ cells; Dose 2: 3×10\^6/kg CAR+ cells; Dose 3: 6×10\^6/kg CAR+ cells.

Timeline

• Start date: 2018-06-08
• Primary completion: 2021-06-04
• Completion: 2021-06-04
• First posted: 2019-08-26
• Last updated: 2026-02-11

Locations

1 site across 1 country: China