RecruitingNot ApplicableNCT06890065

JY231(JY231) Injection for the Treatment of Relapsed/Refractory B Cell Lymphoma/ Leukemia

An Early-Phase Exploratory Clinical Study of JY231 Injection in Relapsed/Refractory B-Cell Lymphoma/Leukemia: Safety, Tolerability, and Preliminary Efficacy

Sponsor

Shenzhen Genocury Biotech Co., Ltd.

Enrollment

20 participants

Start Date

Mar 1, 2025

Study Type

INTERVENTIONAL

Conditions

B Acute Lymphoblastic Leukemia B-Non Hodgkin Lymphoma

Summary

This study is an investigator-initiated single center, single arm clinical study with a target population of patients with relapsed or refractory B cell lymphoma /leukemia. It is an early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of relapsed or refractory B cell lymphoma / leukemia.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests JY231 — a type of CAR-T cell therapy, where the patient's own immune cells are collected, genetically modified to recognize cancer cells, and then infused back — for people with B-cell blood cancers (like certain lymphomas or leukemias) that have come back or stopped responding to treatment. **You may be eligible if...** - You are between 18 and 75 years old - Your cancer cells test positive for a protein called CD19 (found on many B-cell cancers) - You have relapsed or refractory B-cell lymphoma or leukemia (cancer returned or stopped responding) - You have received at least two prior lines of treatment **You may NOT be eligible if...** - Your cancer does not express CD19 - You have severe organ problems (kidney, liver, or heart) - You are pregnant or breastfeeding - You have an active serious infection 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

DRUGJY231 Injection

This is an open-label, single-arm study to evaluate the efficacy and safety of in vivo Chimeric Antigen Receptor T-Cell (CAR-T) therapy in patients with relapsed refractory B-cell lymphoma/ leukemia. Upon enrollment, subjects will receive an intravenous infusion of the JY231 preparation. Following the infusion, subjects will be hospitalized for one month for observation, and subjects will be evaluated for safety and efficacy. Subjects will be followed for up to 2 years to determine if the disease is under control.

Locations(1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

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NCT06890065

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