RecruitingNot ApplicableNCT06689917

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

An Early Exploratory Clinical Study of the Safety, Tolerability and Preliminary Efficacy of JY231 Injection in the Treatment of Relapsed or Refractory B-cell Lymphoma/Leukaemia


Sponsor

Tongji Hospital

Enrollment

20 participants

Start Date

Jan 20, 2025

Study Type

INTERVENTIONAL

Conditions

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 is testing a new cell therapy called JY231 — a type of CAR-T therapy where a patient's immune cells are engineered to attack cancer cells carrying the CD19 protein — for people with B-cell lymphoma or leukemia that has come back or stopped responding to previous treatments. **You may be eligible if...** - You are between 18 and 75 years old - Your cancer cells test positive for CD19 (a protein found on B-cells) - You have relapsed or refractory B-cell lymphoma or leukemia, such as follicular lymphoma, marginal zone lymphoma, or diffuse large B-cell lymphoma - You have received prior standard therapies that have not worked **You may NOT be eligible if...** - You have active brain involvement from your cancer - You have significant organ problems (heart, liver, kidney, lungs) - You have active infections or autoimmune conditions requiring treatment - You are pregnant or breastfeeding 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 study employs two pretreatment regimens: In the lymphodepletion regimen, upon enrollment, subjects undergo leukapheresis followed by 3-5 days of lymphodepleting therapy with fludarabine and cyclophosphamide, culminating in intravenous infusion of JY231 and autologous patient PBMCs via a double-lumen catheter; in the non-lymphodepletion regimen, subjects receive direct intravenous injection of the JY231 preparation immediately after enrollment.


Locations(1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, China

Wuhan, Hubei, China

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NCT06689917


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