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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05472610
Other study ID # BZ019R-A-01
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date June 4, 2021
Est. completion date January 2023

Study information

Verified date July 2022
Source Shanghai Mengchao Cancer Hospital
Contact Zhang Yan, Ph. D
Phone 021-67091122
Email 1r1-7v5o4ef29a@dingtalk.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a single arm,open-label, non-randomized phase 2 study to determine the efficacy of BZ019 in relapsed or refractory CD19+ B-cell Lymphoma subjects.


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Study Design


Related Conditions & MeSH terms


Intervention

Biological:
BZ019
A treatment program will include lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by single-dose of BZ019 administered intravenously (IV).

Locations

Country Name City State
China Shanghai Mengchao Cancer Hospital Shanghai Shanghai

Sponsors (2)

Lead Sponsor Collaborator
Shanghai Mengchao Cancer Hospital Shanghai Cell Therapy Group Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Objective response rate (ORR) Clinical response will be assessed by RECIST 1.1. Month 3
Secondary Pharmacokinetics (PK) Peak Plasma Concentration (Cmax) Month 12
Secondary Pharmacodynamics (PD) PD of IL-2, IL-4, IL-6,IL-10, IL-15, IFN-?, TNF-a will be analysed after CAR T cell infusion Month 12
Secondary Quality of life(QOL) Quality of life will be assessed by EQ-5D health Index scale Month 12
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