NCT03751293Unknown1 期
A Phase Ⅰ Study Evaluating Safety and Efficacy of C-CAR088 Treatment in Subjects With Relapsed or Refractory Multiple Myeloma
Hebei Yanda Ludaopei Hospital1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年1月8日最近更新:
适应症
干预措施
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
- Safety: The incidence of treatment-emergent adverse events (TEAEs)
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 patient.
详细描述
The study will include the following sequential phases: Screening, Pre-Treatment (Cell Product Preparation, Lymphodepleting Chemotherapy), C-CAR088 infusion and Follow-up.
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
- •Volunteered to participate in this study and signed informed consent.
- •Age 18-70 years old, male or female.
- •Meet the internationally accepted Criteria for the diagnosis of multiple myeloma (IMWG diagnostic criteria 2014).
- •Patients with relapsed or refractory multiple myeloma who meet at least one of the following conditions:
- •Subjects must have received at least two therapy regimens (including proteasome inhibitor or immune-modulator therapy, disease progress or relapse after the last therapy).
- •Subjects have received only one therapy regimen, but the investigators judge that patients have unmet treatment needs or can't get benefit from current treatment options.
- •Subjects have one or more measurable multiple myeloma lesion, must include one of the following conditions:
- •Serum M protein≥1 g/dl(10g/L)
- •Urine M protein≥200 mg/24h
- •Serum free light chain(sFLC): κ/λ ratio abnormal and ≥10 mg/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 -
- •Normal cardiac diastolic function, left ventricular ejection fraction (LVEF) ≥ 50% (detected by echocardiography), no serious arrhythmia.
- •No active pulmonary infections, normal pulmonary function and oxygen saturation ≥ 92% on room air.
- •No contraindications of leukapheresis.
- •Expected survival > 12 weeks.
- •Female subjects in childbearing age, their serum or urine pregnancy test must be negative,until 7 days before cell therapy and all subjects must agree to take effective contraceptive measures during the trial.
排除标准
- •Have a history of allergy to cellular products.
- •Any kind of these laboratory testing: including but not limited to,serum total bilirubin≧1.5mg/dl, serum ALT, AST≧2.5×ULN, serum creatinine≧2.0mg/dl, Hb (hemoglobin)<80g/L, neutrophils<1000/mm^3, platelets≦50000/mm^3 or platelet count maintained by transfusion.
- •Subjects with the following clinically significant cardiovascular diseases.
- •A history of craniocerebral trauma, consciousness disorder, epilepsy, severe cerebral ischemia or hemorrhagic disease.
- •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.
- •The investigators judge that any increase in the risk of the subject or interference with the results of the trial.
- •After allogeneic hematopoietic stem cell transplantation.
- •Plasma cell leukemia.
- •One week before leukapheresis and one week before CART cell infusion, treated with more than 5mg/d prednisone (or equal amount of other corticosteroids).
- •Subjects with any autoimmune disease or any immune deficiency disease or other disease in need of immunosuppressive therapy.
- •Uncontrolled active infection.
- •Prior treatment with CAR T therapy or any other genetically modified T cell therapy.
- •Live vaccine inoculation within four weeks before enrollment.
- •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 three 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 (Biological)
结局指标
主要结局
Safety: The incidence of treatment-emergent adverse events (TEAEs)
时间窗: 30 days
The incidence of treatment-emergent adverse events (TEAEs)
次要结局
- Overall response rate (ORR)(12 months)
- Progression free survival (PFS)(6 months, 12 months)
- The CART cell duration in vivo(12 months)
- The soluble BCMA changes in peripheral blood(12 months)
研究者
研究点 (1)
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