NCT07284927招募中1 期
Clinical Study of LV009 Injection for the Treatment of Relapsed/Refractory CD19-Positive Hematologic and Lymphoid Malignancies
PersonGen BioTherapeutics (Suzhou) Co., Ltd.1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年12月3日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
This clinical trial is designed as a single-arm, open-label, single-center, investigator-initiated, early-phase study. Its primary objective is to evaluate the safety of LV009 Injection in subjects with relapsed/refractory CD19-positive hematolymphoid malignancies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 70 years (inclusive), irrespective of sex and race.
- •Life expectancy greater than 12 weeks.
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 to
- •Meets the National Comprehensive Cancer Network (NCCN) criteria for relapsed or refractory disease, with a confirmed diagnosis of CD19-positive hematolymphoid malignancy
- •Adequate hepatic, renal, and cardiopulmonary function
- •Absolute lymphocyte count (ALC) ≥ 0.5 × 10⁹/L; Platelet count ≥ 50 × 10⁹/L; CD3-positive T-cell count ≥ 150 cells/μL
排除标准
- •Patients who, in the investigator's judgment at screening, require long-term use of immunosuppressive agents.
- •History of cerebrovascular accident or convulsive seizures within 6 months prior to signing the informed consent form.
- •Presence of other active malignant diseases besides the disease under study, with the exception of carcinoma in situ.
- •Patients with severe cardiac disease, unstable systemic diseases, or chronic progressive neurological disorders, etc.
- •Patients who have received CAR-T therapy or other genetically modified cell therapies prior to screening.
- •Patients who have participated in other clinical studies within 1 month prior to screening.
- •Evidence of central nervous system involvement at the time of screening.
研究组 & 干预措施
LV009 Injection
Experimental
干预措施: LV009 Injection (Biological)
结局指标
主要结局
Safety
时间窗: 2 years
Adverse Events Occurring During the Treatment Period (TEAEs), Serious Adverse Events (SAEs), Replication-Competent Lentivirus (RCL), and Lentiviral Insertion Site Status (Assessed according to the Common Terminology Criteria for Adverse Events, Version 5.0, NCI CTCAE v5.0)
次要结局
未报告次要终点
研究者
研究点 (1)
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