LCAR-B4822M-02 Cells in Treating Relapsed/Refractory (R/R) Multiple Myeloma
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
- Occurrence of treatment related adverse events
研究概览
简要总结
This is a single arm, open-label, phase 1 study, to determine the safety and efficacy of LCAR-B4822M CAR-T cells in treating patients diagnosed with refractory/relapsed multiple myeloma (r/r MM).
详细描述
Multiple myeloma (MM) is a usually incurable malignancy of plasma cells. Current therapies for multiple myeloma often cause remissions, but nearly all patients eventually relapse, there is an unmet clinical needs for these patients. B-cell maturation antigen (BCMA) is a protein expressed by normal plasma cells and the malignant plasma cells of multiple myeloma, and it was supposed to be a promising target for r/r MM.
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 73 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have a confirmed prior diagnosis of active multiple myeloma as defined by the updated IMWG criteria.
- •Patients with refractory multiple myeloma. Clear BCMA expression must be detected on malignant plasma cells from either bone marrow or a plasmacytoma by flow cytometry or immunohistochemistry.
- •Refractory disease：1) At least 3 prior regimens, which must at least have contained bortezomi. or 2) other circumstances identified by clinical doctors.
- •Relapse criteria in NCCN clinical practice guidelines in Oncology: Multiple Myeloma (2016.V2)
排除标准
- •Women of child-bearing potential or who are pregnant or breastfeeding. Have any active and uncontrolled infection: hepatitis B, hepatitis C, HIV, or other fatal viral and bacterial infection.
- •Systemic corticosteroid steroid therapy of greater than 5 mg/day of prednisone or equivalent dose of another corticosteroid are not allowed within 2 weeks prior to either the required leukapheresis or the initiation of the conditioning chemotherapy regimen.
- •Patients with any uncontrolled intercurrent illness or serious uncontrolled medical disorder.
- •Patients with CNS metastases or symptomatic CNS involvement (including cranial neuropathies or mass lesions and spinal cord compression).
- •History of allogeneic stem cell transplantation. Have active acute or chronic graft-versus-host-disease (GVHD), or require immunosuppressant medications for GVHD, within 6 months of enrollment.
- •Patients with active autoimmune skin diseases such as psoriasis or other active autoimmune diseases such as rheumatoid arthritis.
研究组 & 干预措施
LCAR-B4822M treatment group
r/r multiple myeloma patients will be treated with LCAR-B4822M CAR-T cells with a escalation approach, 0.5x10^6- 2.0x10^6 CAR-T cells/kg.
干预措施: LCAR-B4822M CAR-T Cell Immunotherapy (Drug)
结局指标
主要结局
Occurrence of treatment related adverse events
时间窗: Day 1-30 days after injection
Assessed by CTCAE v4.0
次要结局
- Anti-myeloma responses to LCAR-B4822M cell treatment(Day 1-36 months after injection)
- Anti-myeloma responses to LCAR-B38M cell treatment(Day 1-36 months after injection)