NCT06689917

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• 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. This study incorporates two pretreatment regimens: lymphodepletion and non-lymphodepletion. In the lymphodepletion regimen: Upon enrolment, leukapheresis will be performed. Subjects will then undergo 3-5 days of lymphodepleting therapy with fludarabine and cyclophosphamide, followed by concomitant intravenous infusion of the JY231 preparation and autologous peripheral blood mononuclear cell(PBMC) via a double-lumen catheter. In the non-lymphodepletion regimen: Patients will receive direct intravenous injection of the JY231 preparation. Following infusion, subjects will undergo safety and efficacy assessments for up to 3 months. For those achieving sustained remission at 3 months post-infusion, follow-up will be conducted for at least 24 months to evaluate disease control status.

Conditions

• B-ALL
• B-NHL

Interventions

Type	Name	Description
DRUG	JY231 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.

Timeline

• Start date: 2025-01-20
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-11-15
• Last updated: 2025-07-08

Locations

1 site across 1 country: China