JY231(JY231) Injection for the Treatment of Relapsed or Refractory B Cell Lymphoma/ Leukemia
- Registration Number
- NCT06678282
- Lead Sponsor
- Shenzhen Genocury Biotech Co., Ltd.
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description JY231 Injection for the Treatment of relapsed or refractory B cell lymphoma/ leukemia JY231 Injection Subjects who meet the Inclusion Criteria will receive intravenous JY231. JY231 infusion will produce in vivo CAR-T cells in the body.
- Primary Outcome Measures
Name Time Method Incidence of adverse events(AE) after infusion Day 28、Month 2、Month 3、Month 6、Month 12、Month 18、Month 24 The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included.
Maximum Tolerated Dose(MTD) Up to 28 days after infusion MTD will be determined based on Dose-Limiting Toxicity(DLTs) observed during the first 28 days of study treatment.
- Secondary Outcome Measures
Name Time Method Objective Response Rate Up to 3 months after infusion Objective Response Rate(ORR) is defined as the proportion of subjects achieving complete remission(CR) and partial response(PR)
Trial Locations
- Locations (1)
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhenzhou, Henan, China