A Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of the LVIVO-TaVec200 Product in the Treatment of Relapsed/Refractory Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 5
- 主要终点
- Incidence, severity and type of TEAEs (Treatment-emergent Adverse Events)
研究概览
简要总结
This is a prospective, single-arm, open-label dose-escalation clinical study to evaluate LVIVO-TaVec200 in the treatment of relapsed/refractory multiple myeloma.
详细描述
This is a prospective, single-arm, open-label dose-escalation and dose-expansion study, designed to evaluate the safety, tolerability, anti-tumor efficacy profile, and pharmacokinetic characteristics of the LVIVO-TaVec200 in subjects with relapsed/refractory multiple myeloma who have failed at least 3 lines of prior standard therapies. The subject 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 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 ≥ 18 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Has measurable lesions
- •Relapsed and/or refractory multiple myeloma
- •Life expectancy≥ 3 months
- •Clinical laboratory values meet screening visit criteria
- •Adequate organ function.
排除标准
- •Prior antitumor therapy with insufficient washout period ;
- •Prior treatment targeting GPRC5D;
- •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).
- •Any condition deemed by the investigator as rendering the subject unsuitable for participation in this study.
研究组 & 干预措施
LVIVO-TaVec200 product
Each subject will be given a single-dose LVIVO-TaVec200 product infusion at each dose level
干预措施: LVIVO-TaVec200 product (Biological)
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-TaVec200 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-TaVec200 infusion (Day 1)
CAR positive T cells and CAR transgene percentage of in peripheral blood after LVIVO-TaVec200 infusion
Pharmacokinetics in bone marrow
时间窗: Through study completion, an average of 2 years after LVIVO-TaVec200 infusion (Day 1)
CAR positive T cells and CAR transgene percentage of in bone marrow after LVIVO-TaVec200 infusion
The recommended Phase II dose (RP2D) for this cell
时间窗: 30 days after LVIVO-TaVec200 infusion
RP2D established through BF-BOIN design and the DLTs occurring following LVIVO-TaVec200 infusion
次要结局
未报告次要终点