NCT03706547Unknown1 期
Clinical Study of Anti-CD19/BCMA Bispecific Chimeric Antigen Receptors (CARs) T Cell Therapy for Relapsed and Refractory Multiple Myeloma
Peng Liu1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年10月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0
研究概览
简要总结
The goal of this clinical trial is to study the feasibility and efficacy of anti-CD19/BCMA bispecific chimeric antigen receptors (CARs) T cell therapy for relapsed and refractory multiple myeloma.
详细描述
Primary Objectives
- To determine the feasibility ad safety of anti-CD19/BCMA CAR-T cells in treating patients with BCMA-positive multiple myeloma.
Secondary Objectives
- To access the efficacy of anti-CD19/BCMA CAR-T cells in patients with multiple myeloma.
- To determine in vivo dynamics and persistency of anti-CD19/BCMA CAR-T cells.
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
- •Expected survival > 12 weeks
- •Diagnosis of Multiple Myeloma by IMWG updated criteria (2014)
- •Pathology demonstrated that BCMA-poitive malignant plasma cells exited in bone marrow or plamacytoma
- •Exited measurable lesions and in accordance with one of the following test indicators: serum M protein≥1 g/dl; urine M protein≥200 mg/24h; serum free light chain≥10 mg/dl; diagnosis of plasmacytoma by biopsy
- •The criteria for relapsed and refractory multiple myeloma: patients previously received at least 3 different prior treatment regimens for multiple myeloma, including protein inhibitors (eg: Bortezomib), and immunomodulator (eg: Revlimid), and have disease progression in the past 60 days
- •At least 90 days after stem cell transplantation
- •Clinical performance status of ECOG score 0-2
- •Creatinine≤2.0 mg/dl
- •Bilirubin≤2.0 mg/dl
- •The ALT/AST value is lower than 2.5-fold of normal value
- •Accessible to intravenous injection, and no white blood cell collection contraindications
- •Sexually active patients must be willing to utilize one of the more effective birth control methods for 30 days after the CTL infusion. Male partner should use a condom
- •5mg/day dose of Prednisone or other equivalent steroid hormone drugs (eg: Dexamethasone) were not used for two weeks before apheresis and CAR-T infusion
- •Able to understand and sign the Informed Consent Document.
排除标准
- •Patients with symptoms of central nervous system
- •Patients with second malignancies in addition to multiple myeloma
- •Active hepatitis B or C, HIV infections
- •Any other active diseases could affect the enrollment of this trial
- •Long term use of immunosuppressive agents after organ transplantation, except currently receiving or recently received glucocorticoid treatment
- •Patients with organ failure
- •Women of child-bearing potential who are pregnant or breastfeeding during therapy, or have a planned pregnancy with 2 months after therapy
- •A history of mental illness and poorly controlled
- •Women of child-bearing potential who are not willing to practice birth control from the time of enrollment on this study and for 2 months after receiving the preparative regimen. Women of child bearing potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion
- •Patients who are accounted by researchers to be not appropriate for this test
- •Subjects suffering disease affects the understanding of informed consent or complying with study protocol
研究组 & 干预措施
anti-CD19/BCMA CAR-T cells
Experimental
- Chemotherapy with a classic combination with fludarabine and cyclophosphamide;
- Administration with anti-CD19/BCMA CAR-T cells in the BCMA-positive multiple myeloma patients.
干预措施: anti-CD19/BCMA CAR-T cells (Biological)
anti-CD19/BCMA CAR-T cells
Experimental
- Chemotherapy with a classic combination with fludarabine and cyclophosphamide;
- Administration with anti-CD19/BCMA CAR-T cells in the BCMA-positive multiple myeloma patients.
干预措施: Fludarabine (Drug)
anti-CD19/BCMA CAR-T cells
Experimental
- Chemotherapy with a classic combination with fludarabine and cyclophosphamide;
- Administration with anti-CD19/BCMA CAR-T cells in the BCMA-positive multiple myeloma patients.
干预措施: Cyclophosphamide (Drug)
结局指标
主要结局
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0
时间窗: 6 months
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0
次要结局
- Overall remission rate defined by the standard response criteria for myeloma for each arm(8 weeks)
- Duration of CAR-positive T cells in circulation(6 months)
研究者
Peng Liu
Professor
Shanghai Zhongshan Hospital
研究点 (1)
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