Clinical Trial for the Safety and Efficacy of BCMA CAR-T Cell Therapy for Newly Diagnosed Multiple Myeloma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity (DLT)
研究概览
简要总结
Clinical Trial for the Safety and Efficacy of BCMA CAR-T Cell Therapy for Newly Diagnosed Multiple Myeloma
详细描述
This is a single arm, open-label, single-center study. This study is indicated for newly diagnosed multiple myeloma. The selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 40 patients will be enrolled. Primary objective is to explore the safety and efficacy
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Age and gender unlimited;
- •2.According to the IMWG2014 standard, diagnosis as multiple myeloma;
- •3.According to the MSMART 3.0 standard, it is defined as a high-risk multiple myeloma;
- •4.Abnormal plasmocyte BCMA expression positive;
- •5.Echocardiography shows the left ventricular ejection score (LVEF) ≥50%;
- •6.The subject has no lung activity infection;
- •7.Expected life time is more than 3 months;
- •8.ECOG score 0-2 score;
- •9.Voluntarily participate in the trial and sign the informed consent form.
排除标准
- •1.Patients with the history of epilepsy or other CNS disease;
- •2.Patients with prolonged QT interval time or severe heart disease;
- •3.Pregnant or breastfeeding;
- •4.Active infection with no cure;
- •5.Patients with active hepatitis B or C infection;
- •6.Previously treated with any genetic therapy;
- •7.The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
- •8.Serum creatinine > 2.5mg/dl or ALT / AST > 3 times ULN or bilirubin > 2.0mg/dl;
- •9.Those who suffer from other uncontrolled diseases are not suitable to join the study;
- •10.HIV infection;
- •11.Any situation that the researchers believe may increase the risk of patients or interfere with the test results.
研究组 & 干预措施
Treatment Group
This is a single arm clinical trial.
干预措施: BCMA CAR-T cells (Drug)
结局指标
主要结局
Dose-limiting toxicity (DLT)
时间窗: Baseline up to 28 days after BCMA CAR T-cells infusion
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Incidence of treatment-emergent adverse events (TEAEs)
时间窗: Baseline up to 2 years after BCMA CAR T-cells infusion
Incidence of treatment-emergent adverse events \[Safety and Tolerability\]
次要结局
- Multiple Myeloma (MM), Overall response rate (ORR)(At Month 1, 3, 6, 12, 18 and 24)
- Partial response Rate (PRR)(Up to 2 years after BCMA CAR T-cells infusion)
- Overall survival(Up to 2 years after BCMA CAR T-cells infusion)
- Complete response rate(CRR)(Baseline up to 2 years after BCMA CAR T-cells infusion)
研究者
He Huang
Clinical Professor
Zhejiang University