NCT03093168Unknown1 期
A Phase I Clinical Trial of T-Cells Targeting B-Cell Maturation Antigen for Subjects With BCMA-positive Multiple Myeloma
The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2017年2月15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
- 10
- 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-B-Cell Maturation Antigen (BCMA) expressing T cells in treating patients with multiple myeloma.
详细描述
Primary Objectives
- To determine the feasibility ad safety of BCMA CAR-T cells in treating patients with multiple myeloma.
- To determine in vivo dynamics and persistency of BCMA CAR-T cells.
- To access the efficacy of BCMA CAR-T cells in patients with multiple myeloma.
Secondary Objectives
- To assess the bone marrow and tumor migration of BCMA CAR-T cells.
- To investigate the tumor killing capability of BCMA CAR-T cells in vitro
- To investigate the possibility of host immune response to the mouse derived BCMA scFv, and evaluate its correlation to CAR-T persistence.
- To correlate the subsets and differentiation of BCMA CAR-T cells to observed anti-tumor efficacy.
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 MWG criteria 20
- •Patients previously received at least 3 different prior treatment regimens for multiple myeloma, including alkylating agent, protein inhibitors, and immunomodulator, and have disease progression in the past 60 days
- •Important organs function enough to tolerate this therapy
- •At least 90 days after stem cell transplantation
- •Clinical performance status of ECOG score 0-4
- •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
- •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
- •Suffering severe cardiovascular or respiratory disease
- •Poorly controlled hypertension
- •Long term use of immunosuppressive agents after organ transplantation, except currently receiving or recently received glucocorticoid treatment
- •A history of mental illness and poorly controlled
- •Screening showing target cell transduction efficacy is lower than 30%, or T cell proliferation is not enough for infusion (less than 5 fold)
- •Occurrence of unstable pulmonary embolism, deep vein thrombosis, or other major arterial/venous thromboembolic events 30 days prior to assignment
- •Women of child-bearing potential who are pregnant or breastfeeding during therapy, or have a planned pregnancy with 2 months after therapy
- •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
- •Active systemic infections or uncontrolled infection within 14 days prior enrollment
- •Subjects suffering disease affects the understanding of informed consent or complying with study protocol
研究组 & 干预措施
anti-BCMA CAR-T
Experimental
Administration of anti-BCMA:TCRζ-4-1-BB CAR-T cells to patients with multiple myeloma
干预措施: Anti-BCMA CAR-T cells (Biological)
anti-BCMA CAR-T
Experimental
Administration of anti-BCMA:TCRζ-4-1-BB CAR-T cells to patients with multiple myeloma
干预措施: Fludarabine (Drug)
anti-BCMA CAR-T
Experimental
Administration of anti-BCMA:TCRζ-4-1-BB CAR-T cells to patients with multiple myeloma
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
- Duration of CAR-positive T cells in circulation(6 months)
- Total number of CAR-positive T cells infiltrated into lymphoma tissue(6 months)
- Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm(8 weeks)
研究者
研究点 (1)
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