NCT05325801尚未招募1 期
An Open-Label, Dose Finding Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of BMCA and GPRC5D Dual Target CAR-T Cells Therapy in Patients With Relapsed or Refractory Multiple Myeloma
Zhejiang University0 个研究点目标入组 9 人开始时间: 2022年4月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 9
- 主要终点
- Incidence, severity AEs/SAEs
研究概览
简要总结
An Open-Label, Dose Finding Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of BMCA and GPRC5D dual target CAR-T cells therapy in Patients with 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated, written informed consent prior to any study specific procedures;
- •Estimated life expectancy of minimum of 12 weeks;
- •ECOG 0-2;
- •Diagnosed as multiple myeloma according to the IMWG criteria;
- •Evidence of cell membrane GPRC5D and/or BCMA expression, as determined by a validated immunohistochemistry (IHC) or flow cytometry of tumor tissue; Subjects should have measurable disease. At least meet one of the following criteria:
- •If IgG type MM, serum M protein ≥10g/L; if IgA, IgD, IgE or IgM type MM, serum M protein ≥5g/L;
- •urine M protein level ≥0.2g(200mg/24h);
- •light chain type MM, serum free light chain (sFLC) ≥ 100mg / L and K/ λ FLC ratio is abnormal;
- •there are extramedullary lesions;
- •Subjects have had at least 3 prior lines of therapy including chemotherapy based on proteasome inhibitors (PIs) and immunomodulatory agents (IMiDs);
- •Adequate organ functions
排除标准
- •Active smoldering multiple myeloma;
- •Active plasma cell leukemia;
- •With organ amyloidosis;
- •Central nervous system (CNS) involvement;
- •Pregnant or breastfeeding;
- •Hepatitis B virus (HBV) surface antigen (HBsAg) or hepatitis B core antibody-positive and detectable HBV DNA in peripheral blood; Hepatitis C virus (HCV) antibody and hepatitis C virus RNA in peripheral blood; Human immunodeficiency virus (HIV) antibody
- •Uncontrolled Hypertension hypertension defined as a blood pressure (BP) ≥150/95 mmHg; Symptomatic heart failure per New York Heart Association Classification Class II, III or IV), Mean resting corrected QT interval corrected by Fridericia's formula (QTcF) > 470 msec (female), 450 msec (male) obtained from ECG; Baseline left ventricular ejection fraction (LVEF) below institution's lower limit of normal (LLN) or <50%;
- •Have a history of another primary malignancy within 5 years prior to starting study treatment. Exceptions here are as follows: the disease under study; adequately treated basal or squamous cell carcinoma of the skin; cancer of the cervix in situ.
结局指标
主要结局
Incidence, severity AEs/SAEs
时间窗: 2 years after CAR-T cell infusion
次要结局
- Duration of response (DOR)(2 years after CAR-T cell infusion)
- Concentration of CAR-T cells(2 years after CAR-T cell infusion)
- Overall survival (OS)(2 years after CAR-T cell infusion)
- Percentage of Patients With Negative Minimal Residual Disease (MRD)(2 years after CAR-T cell infusion)
- Progression-free survival (PFS)(2 years after CAR-T cell infusion)
- Objective response rate (ORR)(2 years after CAR-T cell infusion)
研究者
He Huang
Prof.
Zhejiang University
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