RecruitingEarly Phase 1NCT06514768

JY231 (JY231) Injection for the Treatment of B-cell Acute Lymphoblastic Leukemia (B-ALL)

Early Exploratory Clinical Study on the Safety, Tolerability and Preliminary Efficacy of JY231 Injection in the Treatment of Acute B Lymphoblastic Leukemia


Sponsor

920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

Enrollment

20 participants

Start Date

Jun 20, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of B-cell acute lymphoblastic leukemia (B-ALL)


Eligibility

Max Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing JY231, a type of immune cell therapy called CAR-T cell therapy, specifically engineered to target the CD19 protein on cancer cells, in people with relapsed or hard-to-treat B-cell acute lymphoblastic leukemia (B-ALL), a type of blood cancer. **You may be eligible if...** - You are up to 75 years old (children and adults are eligible) - Your leukemia has been confirmed to have CD19-positive cells (shown by flow cytometry or histology) - Your bone marrow shows more than 5% cancerous lymphocytes, or residual disease has been confirmed - Your physical performance score is 3 or below (ECOG) - Your liver, kidney, and heart function are within acceptable limits - Your expected survival is more than 3 months **You may NOT be eligible if...** - You have active uncontrolled infection including HIV, hepatitis B, or hepatitis C - You have severe heart disease or significant heart rhythm problems - You are pregnant or breastfeeding - You have had prior severe reactions to CAR-T cell therapy 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

BIOLOGICALJY231

Infusion of JY231 Injection by dose of 1-10×10\^6 Transduction Units (TU)/kg、1-5×10\^7 TU/kg、5-10 ×10\^7 TU/kg. Administration method: intravenous infusion、Splenic artery infusion、Lymph node infusion; Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion (PI evaluation is required)


Locations(1)

920th HJointLogistics

Kunming, Yunnan, China

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NCT06514768


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