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Human CD19 Targeted T Cells Injection(CD19 CAR-T) Therapy for Relapsed and Refractory B-cell Non-Hodgkin's Lymphoma

B-cell Non-Hodgkin's Lymphoma Clinical Trial

Official title:
A Phase Ⅱ Clinical Study Evaluating the Efficacy and Safety of Human CD19 Targeted T Cells Injection (CD19 CAR-T) Therapy for Relapsed and Refractory B-cell Non-Hodgkin's Lymphoma

Clinical Trial Summary

A Phase Ⅱ Clinical Study Evaluating the Efficacy and Safety of Human CD19 Targeted T Cells Injection (CD19 CAR-T) Therapy for R/R B-NHL. Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of CD19 CAR+ T cells.

Clinical Trial Description

Subjects with relapsed and refractory B-cell non-Hodgkin's lymphoma would be selected if subjects meet all criteria evaluated by physical exams, blood tests, electrocardiograph, computedtomography （CT）/magnetic resonance Imaging(MRI)/positron emission tomography（PET）, tumor assessments, etc. Subjects would be hospitalized to receive the infusion of CD19 CAR+ T cells after lymphodepleting regimen, with the observation and evaluation of efficacy and safety. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05436223
Study type Interventional
Source Hrain Biotechnology Co., Ltd.
Contact Xuedong Sun, M.D.
Phone +8615811287219
Email sunxuedong@dashengbio.com
Status Recruiting
Phase Phase 2
Start date August 9, 2021
Completion date August 9, 2026
View Details
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