Clinical Study to Evaluate the Safety and Efficacy of IM21 CAR-T Cells in the Treatment of Elderly Patients With Relapsed or Refractory Multiple Myeloma
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Incidence of adverse events within 1 month after CAR-T cell infusion
研究概览
简要总结
This is a single center study to assess the efficacy and safety of IM21 CAR-T cells in adult with R/R multiple myeloma in China.
详细描述
In this study, about 10 patients with relapsed or refractory multiple myeloma aged ≥60 years were recruited for IM21 CAR-T cell single transfusion therapy. The safety and tolerability of the treatment were evaluated, and the curative effect was initially observed. The research plan includes five stages: screening stage, cell collection stage, chemotherapy pretreatment stage, infusion stage and follow-up stage.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with relapsed or refractory multiple myeloma who had received at least second line regular treatment failure;
- •Age ≥60 years old;
- •The expected survival time is more than 3 months;
- •ECOG score is 0-2;
- •Those who voluntarily participate in the study and sign the informed consent;
- •Hemoglobin (Hb)≥80g/L; Absolute count of neutrophils (ANC) >1×10^9/L Total platelet count (PLT)≥35×10^9/L;
- •left ventricular ejection fraction > 45%.
排除标准
- •High-risk viscera-involved patients: the tumor invaded the gastrointestinal tract, lung, pericardium and one of the great vessels;
- •Those who have graft versus host disease and need to use immunosuppressive agents;
- •Use of systemic steroids in combination within 5 days prior to the blood collection period (except for recent or current use of inhaled steroids);
- •Active hepatitis B or C virus, HIV or other untreated active infected persons;
- •Any circumstance that, in the opinion of the investigator, may increase the risk to the subject or interfere with test results;
- •Patients who use chemotherapy or radiotherapy within 3 days before the blood collection stage.
研究组 & 干预措施
IM21 CAR-T cells
IM21 CAR-T cells administrated in a dosage to be selected by physician from a specific range.
干预措施: IM21 CAR-T cells (Drug)
结局指标
主要结局
Incidence of adverse events within 1 month after CAR-T cell infusion
时间窗: 30days
The primary endpoint wasIncidence of adverse events within 1 month after CAR-T cell infusion
次要结局
- Objective Response Rate(ORR) at 90 days(90days)