A Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of the LVIVO-TaVec400 Product in the Treatment of Relapsed/Refractory Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 38
- 试验地点
- 6
- 主要终点
- Dose-limiting toxicity (DLT) incidence rate and the incidence, severity and type of adverse events (TEAEs) during treatment.
研究概览
简要总结
This is a prospective, single-arm, open-label dose-escalation clinical study to evaluate LVIVO-TaVec400 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-TaVec400 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 ;
- •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).
- •Those who have experienced life-threatening allergic reactions, hypersensitivity reactions or intolerances to the excipients and related additives of the investigational drug; or those with a previous history of severe allergic reactions (such as hypersensitivity reactions, or those for whom the investigator assesses the need to use glucocorticoids to prevent severe immune-related reactions such as allergic reactions).
- •Any condition deemed by the investigator as rendering the subject unsuitable for participation in this study.
- •Also enrolled in other clinical studies.
研究组 & 干预措施
LVIVO-TaVec400 product
Each subject will be given a single-dose LVIVO-TaVec400 product infusion at each dose level
干预措施: LVIVO-TaVec400 product (Biological)
结局指标
主要结局
Dose-limiting toxicity (DLT) incidence rate and the incidence, severity and type of adverse events (TEAEs) during treatment.
时间窗: Through study completion, an average of 2 years after LVIVO-TaVec400 infusion (Day 1)
Determine the recommended dose (RP2D) for the treatment of this research formulation in the Phase II clinical trial.
时间窗: Through study completion, an average of 2 years after LVIVO-TaVec400 infusion (Day 1)
Pharmacokinetics in peripheral blood
时间窗: Through study completion, an average of 2 years after LVIVO-TaVec400 infusion (Day 1)
CAR positive T cells and CAR transgene percentage of in peripheral blood after LVIVO-TaVec400 infusion
Pharmacokinetics in bone marrow
时间窗: Through study completion, an average of 2 years after LVIVO-TaVec400 infusion (Day 1)
CAR positive T cells and CAR transgene percentage of in bone marrow after LVIVO-TaVec400 infusion
次要结局
未报告次要终点