Clinical Study on the Safety and Effectiveness of Autologous Hematopoietic Stem Cell Transplantation Combined With CAR-T Cells in the Treatment of Refractory and Relapsed Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity (DLT)
研究概览
简要总结
Clinical Study on the Safety and Effectiveness of Autologous Hematopoietic Stem Cell Transplantation Combined With CAR-T Cells in the Treatment of Refractory and Relapsed Multiple Myeloma
详细描述
This is a prospectiv , single arm, open-label, single-center study. This study is indicated for refractory and relapsed multiple myeloma. It aims to evaluate the safety and effectiveness of autologous hematopoietic stem cell transplantation combined with BCMA CAR-T to treat refractory and relapsed multiple myeloma. The main research is completely alleviated, overall reaction rate, and recurrence rate,etc. 50 patients will be enrolled.
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
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1、BCMA positive accompanied by refractory/relapsed and resistance;
- •2、Patients with the tumor load is high and cannot be transplanted directly, before transplantation. Reduce the load through CAR-T treatment to prepare for transplantation;
- •3、Patient relapses after transplantation,donor lymphocyte infusion Invalid. The donor cells in the recipient body can be used or the donor cells can be collected directly.Prepare CAR-T to prevent recurrence and induce relapsing;
- •4、Repeated MRD (+) refractory drug resistant cases;
- •5、Male or female, 30-75 years old;
- •6、Anticipated survival time more than 12 weeks
- •7、Transplant subjects, regardless of their previous treatment, are eligible for inclusion after relapse；
- •8、Patients had a negative urine pregnancy test before the start of administration and agreed to take effective contraceptive measures during the test period until the last follow-up;
- •9、Those who 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
Refractory and relapsed multiple myeloma
干预措施: BCMA CAR-T cells injection (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: 24 months after cell infusion
Incidence of treatment-emergent adverse events \[Safety and Tolerability\]
次要结局
- overall response rate(Up to 30 months)
- Progression-free survival (PFS)(Month 6,12,18and 24)
- Complete response rate(CRR)(Baseline up to 2 years after BCMA CAR T-cells infusion)
- Overall survival (OS)(Month 6,12,18and 24)
- Duration of response(DOR)(Month 6,12,18and 24)
研究者
He Huang
The President of The First Affiliated Hospital, College of Medicine, Zhejiang University
Zhejiang University