NCT07628582尚未招募1 期
An Open-label Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the LVIVO-TaVec122 Product in Subjects With Relapsed/Refractory B-cell Malignancies
The First Affiliated Hospital with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2026年9月15日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 48
- 试验地点
- 1
研究概览
简要总结
This is a single-arm, open-label and dose-escalation clinical study to evaluate the LVIVO-TaVec122 product in adult subjects with Relapsed/Refractory B-cell Malignancies.
详细描述
This is a single-arm, open-label clinical study to evaluate the safety, tolerability and efficacy of LVIVO-TaVec122 product in adult subjects with Relapsed/Refractory B-cell Malignancies. Subjects who meet the defined eligibility criteria will be enrolled with a core study period of approximately 2 years, including the screening, bridging therapy(if needed), treatment, and follow-up.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects voluntary agreement to provide written informed consent.
- •Age ≥ 18 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •At least one evaluable tumor lesion.
- •Relapsed and/or refractory Non-Hodgkin Lymphoma (NHL) , and relapsed and/or refractory Chronic Lymphocytic Leukemia (CLL) with treatment indications.
- •Clinical laboratory values meet screening visit criteria.
- •Adequate organ function.
排除标准
- •Prior antitumor therapy with insufficient washout period.
- •Prior treatment with allo-Hematopoietic stem cell transplantation (HSCT) or gene therapies.
- •Patients who are positive for hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C antibody (HCV-Ab), hepatitis C virus ribonucleic acid (HCV RNA), and human immunodeficiency virus antibody (HIV-Ab).
- •Known life-threatening allergic reaction, hypersensitivity reaction, or intolerance to study drug excipients and related excipients, including but not limited to Human Albumin, or those with a history of severe allergic reactions in the past (such as hypersensitivity reactions, or those with severe immune-related reactions such as the need for glucocorticoids to prevent anaphylaxis as assessed by the investigator).
- •Female subjects who were pregnant, breastfeeding.
- •Any condition deemed by the investigator as rendering the subject unsuitable for participation in this study.
研究者
Lei Fan
Director of lymphoma center
The First Affiliated Hospital with Nanjing Medical University
研究点 (1)
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