RecruitingPhase 1NCT05741359

The Safety and Efficacy of BRL-201 in the Treatment of r/r B Lymphocyte Non-Hodgkin Lymphoma

A Phase I/II Clinical Study of the Safety and Efficacy of CD19-targeted Non-viral PD1 Site-specific Integrated CAR-T Cell Injection (BRL-201) in the Treatment of Relapsed or Refractory B Lymphocyte Non-Hodgkin Lymphoma


Sponsor

Bioray Laboratories

Enrollment

18 participants

Start Date

Apr 25, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multi-center, single-arm, open-label clinical study, and the sample size is set to 12-18 subjects.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a CAR-T cell therapy called BRL-201 — where a patient's own immune cells are modified in the lab to target and destroy cancer cells — in people with relapsed or refractory B-cell non-Hodgkin lymphoma (a type of blood cancer that has come back or stopped responding to prior treatments). **You may be eligible if...** - You are 18 years old or older - You have been confirmed to have aggressive B-cell non-Hodgkin lymphoma that expresses the CD19 protein - Your cancer has relapsed (come back) or is refractory (not responding to treatment) after adequate prior therapy - You have at least one measurable tumor - Your general health is good (ECOG score 0–1), and your heart and lung function are adequate - Your estimated survival is at least 3 months - There is no evidence of the cancer spreading to the brain or spinal fluid **You may NOT be eligible if...** - Your cancer has spread to the central nervous system (brain/spine) - You have severe heart, lung, or other organ problems - Your prior cancer treatments have left you with significant ongoing side effects 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

DRUGCD19-targeted non-viral PD1 site-specific integrated CAR-T cell injection

CD19-targeted non-viral PD1 site-specific integrated CAR-T cell injection


Locations(3)

Wuhan Union Hospital

Wuhan, Hubei, China

Tianjin Institute of Hematology

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT05741359


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