RecruitingPhase 2NCT05436223

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

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


Sponsor

Hrain Biotechnology Co., Ltd.

Enrollment

100 participants

Start Date

Aug 9, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing CAR T-cell therapy — a type of treatment where your own immune cells are engineered in a lab to recognize and kill cancer cells — for people with B-cell Non-Hodgkin's Lymphoma that has come back or stopped responding to treatment. **You may be eligible if:** - You are 18 or older - You have a confirmed diagnosis of B-cell Non-Hodgkin's Lymphoma (including DLBCL, PMBCL, transformed follicular lymphoma, or high-grade B-cell lymphoma) - Your cancer has relapsed or hasn't responded after at least two rounds of treatment, including standard first-line therapy - You are in reasonably good physical condition (ECOG 0–2) - Your life expectancy is more than 12 weeks **You may NOT be eligible if:** - You have never received standard treatment before - You have a different type of lymphoma not listed in the study - Your physical health is too poor to tolerate the treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHuman CD19Targeted T Cells Injection

A single dose of predetermined level CAR-positive T cells will be infused.


Locations(1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

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NCT05436223


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