NCT04295018Unknown1 期
A Phase # Study Evaluating Safety and Efficacy of C-CAR088 Treatment in Subjects With Relapsed or Refractory Multiple Myeloma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The Incidence of adverse events (TEAEs) within 30 days after intravenous infusion of C-CAR088
研究概览
简要总结
This is a single-center, non-randomized study to evaluate the safety and efficacy of C-CAR088 in relapsed or refractory multiple myeloma patients.
详细描述
The study will include the following sequential phases: Screening, Apheresis, Baseline, Pre-Treatment (Cell Product Preparation, Lymphodepleting Chemotherapy), C-CAR088 infusion and Follow-up Visit.
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
- •Age 18-75 years old, male or female;
- •The patient volunteered to participate in the study, and he or his legal guardian signed the Informed Consent;
- •Patients with a clear diagnosis of relapsed or refractory multiple myeloma
- •The patient have one or more measurable multiple myeloma lesion, must include one of the following conditions:
- •Serum M protein≥1.0 g/dL(10g/L)
- •Urine M protein≥200 mg/24h
- •Serum free light chain(sFLC): κ/λ FLC ratio is abnormal and affected FLC ≥10mg / dL
- •Bone marrow sample is confirmed as BCMA-positive by flow cytometry or pathological examination;
- •At least 2 weeks from monoclonal antibody therapy prior to CAR T cell therapy.
- •ECOG scores 0 - 1;
- •Good cardiac and pulmonary organ function;
- •Expected survival time > 12 weeks;.
- •Female subjects of childbearing age must have a negative urine / blood pregnancy test within 7 days before cell therapy and not be in lactation; female or male subjects of childbearing age need to take effective contraception throughout the study.
排除标准
- •Have a history of allergy to cellular products;
- •Laboratory testing occurs when: including but not limited to, serum total bilirubin ≥1.5mg / dl; serum ALT or AST is 2.5 times higher than the upper limit of normal value; serum creatinine ≥2.0mg / dl; hemoglobin <80g / L; absolute neutrophil count <1000 / mm3 or dependent on GCSF or Other growth factors can maintain the centriole count ≥1000 / mm²; platelet count <50000 / mm³ or the above level can be maintained due to platelet transfusion;
- •Presence of clinically significant cardiovascular disease, such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or any heart function Grade 3 (moderate) or Grade 4 (severe) heart disease (according to the New York Heart Association Function Classification method: NYHA); patients with a history of myocardial infarction, cardiac angioplasty or stent implantation, unstable angina pectoris or other clinically significant heart disease within 12 months before enrollment;
- •A history of craniocerebral trauma, consciousness disorder, epilepsy, severe cerebral ischemia or hemorrhagic disease;
- •Need to use any anticoagulant (except aspirin);
- •Patients requiring urgent treatment due to tumor progression or spinal cord compression;
- •Patients with CNS metastasis or symptoms of CNS involvement;
- •After allogeneic hematopoietic stem cell transplantation;
- •Plasma cell leukemia;
- •Patients with autoimmune diseases, immunodeficiency, or other immunosuppressive agents;
- •Uncontrolled active infection;
- •Have used any CAR T cell products or other genetically modified T cell therapy before;
- •Hepatitis B or hepatitis C virus infection (including carriers), syphilis, as well as acquired, congenital immune deficiency diseases, including but not limited to HIV infected persons;
- •Have a history of alcoholism, drug addiction and mental illness;
- •Participated in any other clinical trial within 1 months;
- •The investigators believe that there are other circumstances that are not suitable for the trial.
研究组 & 干预措施
C-CAR088
Experimental
Lymphocytes will be transduced with lentiviral vector containing CAR-BCMA gene
干预措施: C-CAR088 (Drug)
结局指标
主要结局
The Incidence of adverse events (TEAEs) within 30 days after intravenous infusion of C-CAR088
时间窗: 30 days
次要结局
- Overall response rate (ORR)(12 months)
- Progression free survival (PFS)(6 months#12 months)
研究者
研究点 (1)
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