Phase I Study of A CXCR4 Modified BCMA CAR-T in Patients With Refractory and/or Relapsed Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Dose limiting toxicities (DLT)
研究概览
简要总结
Multiple myeloma (MM) is an incurable plasma cell cancer that almost all patients eventually relapse despite advancement in treatment strategies. B-cell maturation antigen (BCMA) is a cell surface receptor that expressed primarily by malignant and normal plasma cells. This study aims to evaluate the safety and tolerance CXCR4 modified BCMA CAR T cells in treating standard treatment failed refractory/relapsed multiple myeloma, and will follow dose-escalating cohorts. The efficacy of CXCR4 modified BCMA CAR T will also be investigated.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18 to 75 years old.
- •The expected survival ≥ 12 week
- •Patients with multiple myeloma that never achieved MR (minor response) or received ≥ 1 line of standard therapy but tumor relapse
- •The liver and renal function is good/adequate organ function; no uncontrolled or active infectious disease
- •Venous channel is unobstructed, which can meet the needs of intravenous drip; no contraindications of mononuclear cell collection
- •Patients can take effective contraceptive measures during the trial period and 1 year after the infusion
- •Voluntary informed consent is given, agree to follow the trial treatment and visit plan
排除标准
- •Patients with other uncontrollable cancer
- •Active hepatitis B, hepatitis C, or HIV infection
- •Other uncontrolled active disease
- •Patients with coronary heart disease, angina pectoris, myocardial infarction, cerebral thrombosis, cerebral hemorrhage or any other severe diseases
- •Patients with uncontrollable hypertension(≥ grade II)
- •Patients with history of uncontrollable mental illness
- •Long-term use of immunosuppressants after organ transplantation (inhaled corticosteroids are excluded)
- •Unstable pulmonary embolism or any arteriovenous embolism 30 days before enrollment;
- •Pregnant or lactating women; Men or women who have a pregnancy plan within a year; The patients cannot guarantee effective contraceptive measures during the trial period;
- •Patients with uncontrollable infectious disease or need systematic treatment within the 14 days of enrollment;
- •Patients had other conditions that were not appropriate for the study determined by the researchers.
结局指标
主要结局
Dose limiting toxicities (DLT)
时间窗: 2 years
Dose Limiting Toxicities (DLTs) during the first 28 days after anti-BCMA CAR-T cell administration
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
时间窗: 24 months
次要结局
- ORR (overall response rate)(3 months，6 months)
- CRR (complete response rate)(3 months)
研究者
Ting Niu
Director of Department of Hematology
West China Hospital