NCT06678282

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

JY231 Injection for the Treatment of Relapsed or Refractory B Cell Lymphoma/ Leukemia - A Safety, Tolerability, and Efficacy Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Shenzhen Genocury Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 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-NHL
• B-ALL

Interventions

Type	Name	Description
DRUG	JY231 Injection	The starting dose of this study was set at 1\~10×10\^6 transduction units (TU) / kg and escalated at 2\~5×107\^TU/kg and 6\~10×10\^7 TU/kg.

Timeline

• Start date: 2023-09-07
• Primary completion: 2026-09-30
• Completion: 2026-12-31
• First posted: 2024-11-07
• Last updated: 2024-11-07

Locations

1 site across 1 country: China