NCT06359509尚未招募早期 1 期
A Phase І Study of BCMA-targeted Chimeric Antigen Receptor T Cell (SYS6020) Injection in Relapsed or Refractory Multiple Myeloma
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology0 个研究点目标入组 10 人开始时间: 2024年4月1日最近更新:
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 主要终点
- Incidence of adverse events (AEs)
研究概览
简要总结
This is a multi-center, phase I trial that studies the efficacy and recommended dose of BCMA CART cells in treating patients with BCMA-positive multiple myeloma (MM) that have not respond or relapsed after chemotherapy. B-cell maturation antigen (BCMA), a cell surface protein expressed on malignant plasma cell, has emerged as a very selective antigen to be targeted in novel immunotherapy for 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. ≥ 18 years of age at the time of signing informed consent;
- •2. Cytology or tissue biopsy meets diagnostic criteria for multiple myeloma (according to IMWG criteria);
- •3. Bone marrow specimens confirmed positive BCMA expression in plasma cells and myeloma cells by immunohistochemistry or flow cytometry (>5%);
- •4. Have measurable disease by International Myeloma Working Group (IMWG) criteria based on one or more of the following findings:
- •Serum M-protein≥ 1 g/dL（≥10 g/L）
- •Urine M-protein ≥ 200 mg/24 hour
- •Involved serum free light chain (FLCs) level≥10 mg/dL with FLCs abnormal ratio (<0.26 或>1.65)
- •5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
- •6. Diagnosis of MM with relapsed or refractory disease and have had at least 1 prior lines of therapy.
排除标准
- •1. Patients with plasmacytic leukemia or Waldenstrom's macroglobulinemia or POEMS syndrome (polyneuropathy, organ enlargement, endocrinopathy, monoclonal protein and skin lesions) or amyloidosis at screening;
- •2. Received any prior CAR-T therapy or BCMA targeted therapy;
- •3. Patients who have received autologous hematopoietic stem cell transplantation (ASCT) within 12 weeks prior to monocyte collection or history of allogeneic stem cell transplantation;
- •4. A history of immunodeficiency, including a positive HIV antibody test;
- •5. Hepatitis B surface antigen (HBsAg) positive and HBV-DNA above the lower limit of measurement or 1000 copies /mL (500 IU/mL), (whichever is lower), HCV antibody positive and HCV-RNA above the lower limit of measurement or 1000 copies /mL (whichever is lower);
- •6. Patients who, in the judgment of the investigator, need but are unable to receive prophylactic treatment for Pneumocystis, Herpes Simplex Virus (HSV), or Herpes Zoster (VZV) prior to initiation of treatment, or Syphilis confirmatory positive;
- •7. History of Bacillus Tuberculosis (TB) treatment within 2 years prior to first medication;
- •8. Patients with a history of interstitial lung disease and/or severe lung function impairment;
- •9. Have an active bacterial, fungal, or viral infection;
- •10.A history of severe cardiovascular disease.
结局指标
主要结局
Incidence of adverse events (AEs)
时间窗: Up to approximately 6 months
Incidence of adverse events (AEs)
Dose limiting toxicities (DLTs)
时间窗: Up to 21 days
Dose limiting toxicities (DLTs)
次要结局
- Percentage of subjects who achieved complete response or strict complete response (CR/sCR)(Up to approximately 6 months)
- Percentage of subjects who achieved very good partial response (VGPR) and higher response rate(Up to approximately 6 months)
- Overall response rate (ORR)(Up to approximately 6 months)
研究者
MEI HENG
Proferssor Cheif Doctor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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