NCT06940960

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Affiliated Hospital of Guangdong Medical University · Academic / Other
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This open-label, single-arm study is designed to evaluate the efficacy and safety of in vivo CAR-T cell therapy in patients with relapsed/refractory B cell lymphoma/leukaemia. Upon enrolment, leukapheresis will be performed and patients will receive 3-5 days of fludarabine and cyclophosphamide lymphodepleting therapy followed by an intravenous infusion of the JY231 preparation. Following the infusion, subjects will be evaluated for safety and efficacy for up to 24 months to determine if the disease is under control.

Conditions

• B Acute Lymphoblastic Leukemia
• B-Non Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	JY231 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.

Timeline

• Start date: 2025-05-30
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2025-04-23
• Last updated: 2025-06-10

Locations

1 site across 1 country: China