A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of the CD19/CD20 Dual-Target in Vivo CAR-T Lentiviral Product in the Treatment of Relapsed/Refractory B-cell Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 10
- 主要终点
- Incidence, severity and type of TEAEs (Treatment-emergent Adverse Events)
研究概览
简要总结
A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of the CD19/CD20 Dual-Target in vivo CAR-T Lentiviral product in the Treatment of Relapsed/Refractory B-cell Malignancies.
详细描述
This is an open-label, dose-escalation/dose extension study to assess the safety, tolerability, and efficacy of CD19/CD20 Dual-Target in vivo CAR-T Lentiviral product in the patient ≥ 18 years of age with relapsed or refractory B-cell Malignancies. Subjects who meet the eligibility criteria will receive a single dose of CD19/CD20 Dual-Target in vivo CAR-T Lentiviral product. The study will include the following sequential phases: 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects voluntarily participate in clinical studies; Fully informed of this study and signed informed consent; Informed consent form must be obtained prior to initiation of any study-related tests or procedures that are not part of the standard treatment for the subject's disease; Good compliance and cooperation with follow-up.
- •Age greater than or equal to
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •At least one evaluable tumor lesion.
- •Relapsed and/or refractory NHL , and relapsed and/or refractory CLL with treatment indications
- •Life expectancy≥ 3 months
- •Clinical laboratory values meet screening visit criteria
- •Adequate organ function;
排除标准
- •Subject eligible for this study must not meet any of the following criteria:
- •Prior antitumor therapy with insufficient washout period ;
- •Prior treatment with lentiviral vector-based 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 DMSO; 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).
- •Lactating women;
结局指标
主要结局
Incidence, severity and type of TEAEs (Treatment-emergent Adverse Events)
时间窗: Through study completion, an average of 2 years after LVIVO-TaVec100 infusion (Day 1)
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Pharmacokinetics in peripheral blood
时间窗: Through study completion, an average of 2 years after LVIVO-TaVec100 infusion (Day 1)
CAR positive T cells and CAR transgene percentage of in peripheral blood after LVIVO-TaVec100 infusion.
Pharmacokinetics in bone marrow
时间窗: Through study completion, an average of 2 years after LVIVO-TaVec100 infusion (Day 1)
CAR positive T cells and CAR transgene percentage of in bone marrow after LVIVO-TaVec100 infusion.
The recommended Phase II dose (RP2D) for this cell therapy
时间窗: 30 days after LVIVO-TaVec100 infusion
RP2D established through 3+3 design and the DLTs occurring following LVIVO-TaVec100 infusion
次要结局
- Overall Response Rate (ORR)(Through study completion, an average 2 years after LVIVO-TaVec100 infusion (Day 1))
- Progression-free survival (PFS)(Through study completion, an average 2 years after LVIVO-TaVec100 infusion (Day 1))
- Overall Survival (OS)(Through study completion, an average 2 years after LVIVO-TaVec100 infusion (Day 1))
- Time to Response (TTR)(Through study completion, an average 2 years after LVIVO-TaVec100 infusion (Day 1))
- Duration of Response (DoR)(Through study completion, an average 2 years after LVIVO-TaVec100 infusion (Day 1))
- Immunogenicity assessment of LVIVO-TaVec100 infusion(Through study completion, an average 2 years after LVIVO-TaVec100 infusion (Day 1))
研究者
Lei Fan
Director of lymphoma center
The First Affiliated Hospital with Nanjing Medical University