BCMA-CD19 cCAR in Relapsed and /or Refractory Multiple Myeloma and Plasmacytoid Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Number of adverse events after BCMA-CD19 cCAR T cells infusion
研究概览
简要总结
This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of BCMA-CD19 cCAR in patients with relapsed and/or refractory multiple myeloma and plasmacytoid lymphoma.
详细描述
BCMA-CD19 cCAR is a compound Chimeric Antigen Receptor (cCAR) immunotherapy with two distinct functional CAR molecules expressing on a T-cell, directed against the surface proteins BCMA and CD19. BCMA-CD19 cCAR is also aimed to treat multiple myeloma, a challenging disease due to the heterogeneity of myeloma cells, which renders single-antigen targeting CAR T-cell therapy ineffective. BCMA-CD19 cCAR is proposed to target both bulky myeloma cells expressing BCMA, and myeloma stem cells expressing CD19 to effectively eradicate the disease.
BCMA-CD19 cCAR is also aimed to treat heterogeneous plasmacytoid lymphoma bearing two types of lymphoma cells, regular lymphoma cells expressing CD19 and plasmacytoid lymphoma cells expressing BCMA. The use of two different targets intends to increase coverage and eradicate cancerous cells before resistance develops in surviving cancer cells that have undergone selective pressures or antigen escape.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent; Patients volunteer to participate in the research
- •Diagnosis is mainly based on the World Health Organization (WHO) 2008
- •Patients have exhausted standard therapeutic options
- •Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 1 weeks
- •Female must be not pregnant during the study
排除标准
- •Patients declining to consent for treatment
- •Prior solid organ transplantation
- •Potentially curative therapy including chemotherapy or hematopoietic cell transplant
- •Prior treatment with BCMAxCD3 or CD19xCD3 bispecific agents
研究组 & 干预措施
BCMA-CD19 cCAR
Dose escalation phase: BCMA-CD19 cCAR T cells transduced with a lentiviral vector to express two distinct units of BCMA and CD19 CARs on a T cell with an escalation approach, 2e6 to 10e6 CAR-T cells/kg
干预措施: BCMA-CD19 cCAR T cells (Biological)
结局指标
主要结局
Number of adverse events after BCMA-CD19 cCAR T cells infusion
时间窗: 2 years particularly the first 28 days after infusion
Determine the toxicity profile of BCMA-CD19 cCAR T cell therapy
次要结局
- Incidence of treatment-emergent adverse events(up to 6 months)