Determining Safety and Maximum Tolerated Dose (MTD) of Anti-BCMA CAR-NK Therapy in Relapsed or Refractory Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Incidence of dose-limiting toxicity (DLTs)
研究概览
简要总结
Immunotherapy has shown promise in the treatment of hematological malignancies, including multiple myeloma. One approach is CAR-NK cell therapy, which involves genetically modifying natural killer (NK) cells to target specific cancer antigens. While CAR-NK therapy offers advantages over CAR-T therapy, such as reduced immune system reactions and lower production time and cost, challenges remain in terms of antitumor efficacy and the tumor microenvironment. Preclinical and early clinical studies have targeted various antigens, including BCMA, with CAR-NK cells in multiple myeloma. To further investigate the potential of BCMA-targeted CAR-NK cell therapy, this study aims to evaluate its safety and determine the maximum tolerated dose (MTD) in patients who have not responded to standard therapy.
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
- 是
入选标准
- •Age 18-80 years with expected survival > 3 months.
- •Confirmed diagnosis of active multiple myeloma with detectable BCMA expression in malignant cells.
- •Relapsed or refractory disease with at least 2 prior lines of treatment, including a proteasome inhibitor and immunomodulator, without achieving significant efficacy.
- •Measurable disease at screening according to IMWG criteria, as defined by any of the following: Serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL or urine M-protein level being as defined； or light chain MM without measurable disease in the serum or the urine； serum immunoglobulin free light chain disease dL and abnormal serum immunoglobulin kappa/lambda free light chain ratio
- •ECOG performance status of 0-
- •Acceptable cardiac, liver, and kidney function.
- •Signed written informed consent.
排除标准
- •Pregnant or lactating women.
- •Uncontrolled active infection, HIV infection, or positive syphilis serology reaction.
- •Active hepatitis B or hepatitis C infection.
- •Recent or current use of glucocorticoids or other immunosuppressors.
- •Severe cardiac, liver, renal insufficiency, diabetes, or other diseases.
- •Participation in other clinical research in the past three months.
研究组 & 干预措施
Relapsed or Refractory Multiple Myeloma
干预措施: Anti-BCMA CAR-NK (Biological)
结局指标
主要结局
Incidence of dose-limiting toxicity (DLTs)
时间窗: 4 weeks
Incidence of dose-limiting toxicity (DLTs) within 4 weeks after infusion, characterized by \>= Grade 3 signs/symptoms according to CTCAE v4.03, to assess safety and tolerability.
Assessment of Maximum Tolerated Dose (MTD)
时间窗: 4 weeks
Overall Remission Rate (ORR)
时间窗: 8 weeks
Overall Remission Rate (ORR) two months after infusion, assessed using International Myeloma Working Group (IMWG) criteria.
次要结局
- Progression-free survival (PFS)(48 weeks)
- Duration of Response (DOR)(48 weeks)
研究者
Masoud Soleimani
Professor
Shahid Beheshti University of Medical Sciences