Study Evaluating the Safety and Efficacy With Sequential Infusion of Humanized CAR-T Cells of Anti-BCAM and Anti-CD19 Against Relapsed and Refractory Multiple Myeloma
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Overall response rate (ORR)
研究概览
简要总结
This is a single arm, open-label, single center study to evaluate the safety and efficacy of BCMA/CD19 CAR-T cells in patients with BCMA+，CD19+ relapsed or refractory multiple myeloma.
详细描述
CD19 has been extensively evaluated as a therapeutic target for relapsed or refractory multiple myeloma by chimeric antigen receptor T cell therapy,this is a single arm, open-label, single center study to preliminary explore the safety, tolerability and cellular pharmacokinetics of Anti-BCMA and Anti-CD19 CAR-T cells in the treatment of relapsed or refractory multiple myeloma.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18-70 years old
- •Estimated Survival time > 12 weeks
- •Relapsed and refractory multiple myeloma were confirmed by physical examination, pathological examination, laboratory examination and imaging
- •Chemotherapy failure or recurrent multiple myeloma
- •Glutamic-pyruvic transaminase, glutamic oxalacetic transaminase< 3 fold of normal level
- •Bilirubin<2.0mg/dl
- •Karnofsky Performance Status>50% at the time of screening
- •Adequate pulmonary, renal, hepatic, and cardiac function
- •Fail in autologous haemopoietic stem cell transplantation
- •Not suitable for stem cell transplantation conditions or abandoned due to conditions
- •Free of leukocytes removal contraindications
- •Voluntarily join CAR-T clinical trial ,Understand and sign written informed consent
排除标准
- •The patient is a pregnant or breastfeeding woman, or is a woman with a pregnancy plan within six months
- •Patients have infectious diseases (such as HIV, active tuberculosis, etc.)
- •The patient is an active hepatitis B or hepatitis C infection
- •Feasibility assessment proves that the efficiency of transduction of lymphocyte is below 10% or the lymphocyte cannot be propagated
- •Abnormal vital signs
- •Subjects with mental or psychological illness who cannot be combined with treatment and efficacy evaluation.
- •Highly allergic constitution or history of severe allergies, especially allergy to interleukin-2
- •General infection or local severe infection, or other infection that is not controlled
- •Dysfunction in lung, heart, kidney and brain
- •Severe autoimmune diseases
- •Other symptoms that are not applicable for CAR-T
结局指标
主要结局
Overall response rate (ORR)
时间窗: 2 year
Assessment of ORR (ORR = sCR+CR+VGPR+PR ) at 1 months of treatment
minimal residual disease（MRD）
时间窗: 2 year
Assessment of MRD negative overall response rate at 3 months of treatment
Progression-free survival (PFS)
时间窗: 2 year
Assessment of Progression-free survival (PFS) at 6 months of treatment
Overall survival (OS)
时间窗: 2 year
Assessment of overall survival (OS) at 6 months of treatment
次要结局
- Expression of CD19 CART cells(2 year)
- Safety (incidence of adverse events defined as dose-limited toxicity)(Study treatment until Week 24)
研究者
LiFei,M.D., Ph.D.
M.D.,Ph.D.
The First Affiliated Hospital of Nanchang University