Universal CAR-T Cells for the Treatment of Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Percentage of patients with treatment related adverse effect
研究概览
简要总结
The aim of this study is to assess the feasibility, safety and efficacy of universal CAR T cells targeting multiple myeloma. Another goal of the study is to learn more about the persistence and function of the universal CAR T cells in the body.
详细描述
Important Regulatory Notice:
This trial record is only for global academic information registration on ClinicalTrials.gov. Neither the sponsor Beijing Meikang Jimian Biotechnology Co., Ltd. nor collaborator Shenzhen Geno-Immune Medical Institute has obtained NMPA clinical trial approval or clinical technology filing permission to carry out interventional cell therapy trials in mainland China.
ClinicalTrials.gov registration alone does not represent legal approval by Chinese health and drug regulatory authorities.
Multiple myeloma (MM) is a malignancy of the plasma cells, which remains a clinical challenge despite advanced therapeutic interventions including novel molecular therapies and stem cell transplantation (SCT).
CAR-T therapy has proven to be a revolutionary treatment for hematological malignancies, but its manufacture is still limited by the high cost, and a long preparation time that is not conducive to timely treatment of patients. In addition, many MM patients suffer from long-term bone marrow suppression caused by tumor growth or prolonged and intense chemotherapies, resulting in exhaustion, aging and functional defects of autologous T cells, which substantially affect the quality of CAR-T cells and the clinical efficacy. The universal CAR-T cells could overcome many of the above problems.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with confirmed multiple myeloma failed curative treatment options (including autologous or allogeneic SCT).
- •Complete remission (CR) cannot be achieved after at least 2 prior therapy regimens.
- •High risk MM in CR1 or CR2 and not eligible for SCT because of age or comorbid diseases.
- •Less than 1 year between last chemotherapy and progression (i.e. most recent progression free interval < 1 year).
- •Relapsed after prior autologous or allogenic SCT with residual disease after at least 1 prior therapy and not eligible for allogeneic SCT.
- •Residual disease after primary therapy and not eligible for ASCT
- •Expected survival > 12 weeks• Creatinine < 2.5 mg/dl• ALT (alanine aminotransferase)/AST (aspartate aminotransferase) < 3x normal
- •Bilirubin < 2.0 mg/dl
- •Any relapse after prior SCT is eligible regardless of other prior therapy
- •Adequate venous access for apheresis, and no other contraindications for leukapheresis
- •Voluntary informed consent is signed
排除标准
- •Pregnant or lactating women
- •Uncontrolled active infection
- •Active hepatitis B or hepatitis C infection
- •Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
- •Previous related CAR-T cell therapy
- •Any uncontrolled active medical disorder that would preclude participation
- •HIV infection
研究组 & 干预措施
Universal CART cells to treat MM
干预措施: MM-specific universal CAR T cells (Biological)
结局指标
主要结局
Percentage of patients with treatment related adverse effect
时间窗: 6 months
percentage of participants with treatment-related adverse events, as assessed by physical examination, vital signs, standard clinical lab tests.
次要结局
- Anti-tumor activity of the universal 4SCAR-T cells after infusion(3 months)
- Anti-tumor activity of fourth generation universal CAR-T cells in patients with relapsed or refractory MM(1 year)