A Phase Ib 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
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Incidence, severity, and category of treatment-emergent adverse events (TEAEs)
研究概览
简要总结
Phase Ib 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 expansion study to assess the safety, tolerability, and efficacy of CD19/CD20 Dual-Target in vivo CAR-T Lentiviral product in adult patient 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 —（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 measurable tumor lesion.
- •Eligible subjects shall meet the criteria and qualification requirements of any one of the expansion cohorts as follows:
- •Cohort 1: Relapsed or refractory large B-cell lymphoma patients who have received at least one line of systemic therapy and have not undergone CAR-T therapy;
- •Cohort 2: High-risk large B-cell lymphoma patients in the first-line setting (who have completed 2 cycles of standard first-line systemic immunochemotherapy);
- •Cohort 3: Relapsed or refractory mantle cell lymphoma patients treated with at least two lines of systemic therapy;
- •Cohort 4: Exploratory cohort including relapsed or refractory indolent lymphoma and other B-cell malignancies.
- •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;
研究组 & 干预措施
CD19/CD20 Dual-Target in vivo CAR-T Lentiviral
Each subject will receive a single dose of CD19/CD20 Dual-Target in vivo CAR-T Lentiviral product infusion.
干预措施: CD19/CD20 Dual-Target in vivo CAR-T Lentiviral (Biological)
结局指标
主要结局
Incidence, severity, and category of treatment-emergent adverse events (TEAEs)
时间窗: Through study completion, an average of 2 years afterCD19/CD20 Dual-Target in vivo CAR-T Lentiviral 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.
Objective response rate (ORR) and complete response (CR) rate (or the proportion of subjects achieving very good partial response [VGPR] or better) assessed per protocol-specified efficacy evaluation criteria stratified by disease type
时间窗: Through study completion, an average 2 years after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion (Day 1)
Objective Response Rate (ORR) is defined as the proportion of subjects who achieve CR or PR after treatment via CD19/CD20 Dual-Target in vivo CAR-T Lentiviral cell infusion
次要结局
- Further evaluation of efficacy endpoints stratified by disease subtype: Time to Response (TTR)(Through study completion, an average 2 years after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion (Day 1))
- Further evaluation of efficacy endpoints stratified by disease subtype: Duration of Response (DOR)(Through study completion, an average 2 years after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion (Day 1))
- Further evaluation of efficacy endpoints stratified by disease subtype: Progression Free Survival (PFS)(Through study completion, an average 2 years after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion (Day 1))
- Further evaluation of efficacy endpoints stratified by disease subtype: Overall Survival (OS)(Through study completion, an average 2 years after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion (Day 1))
- Pharmacokinetics in peripheral blood(Through study completion, an average of 2 years after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion (Day 1))
- Pharmacokinetics in bone marrow(Through study completion, an average of 2 years after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion (Day 1))
- Immunogenicity assessment of CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion.(Through study completion, an average 2 years after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion (Day 1))
研究者
Lei Fan
Director of lymphoma center
The First Affiliated Hospital with Nanjing Medical University