肿瘤细胞治疗研究
英文原题：First-in-Human Study of MDG1011, a TCR-T Therapy Directed Against HLA-A*02:01-Restricted PRAME Antigen for High-Risk Myeloid and Lymphoid Neoplasms.
First-in-Human Study of MDG1011, a TCR-T Therapy Directed Against HLA-A*02:01-Restricted PRAME Antigen for High-Risk Myeloid and Lymphoid Neoplasms.
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入组 CD-TCR-001 I 期部分的患者，在所研究的少数患者中显示出 MDG1011 潜在临床和生物学活性的迹象。
13例入组患者中，9例接受MDG1011治疗，剂量范围为每公斤体重0.1至5×10^6个TCR-T细胞。除临床评估外，还在预设时间点监测与细胞因子释放综合征（CRS）相关的细胞因子、MDG1011的存在及持久性，以及PRAME mRNA水平变化，以评估安全性和潜在生物学活性。
治疗耐受性良好，未观察到剂量限制性毒性（DLT）。最常见的严重不良事件与淋巴细胞清除化疗和/或疾病进展有关。两例患者出现可测量的临床应答，另有两例发生CRS，7例患者骨髓（BM）或外周血（PB）中的PRAME mRNA水平降低，这些表现提示MDG1011 TCR-T疗法具有临床及生物学活性。
CD-TCR-001 I期部分纳入的少数患者中，MDG1011显示潜在临床和生物学活性的迹象。r/r AML患者疾病分期较晚且进展迅速，限制了临床获益。MDG1011安全性可接受，值得进一步研究，尤其可考虑在疾病较早期、肿瘤负荷较低的患者中评估该TCR-T疗法。
Nine of thirteen enrolled patients received MDG1011 at dose levels ranging from 0.1 to 5 10 6 TCR-T cells per kg body weight. In addition to clinical assessments, immune monitoring of cytokines associated with cytokine release syndrome (CRS), presence and persistence of MDG1011, and changes in levels of PRAME mRNA were used to assess safety and potential biological activity at defined time points.
The treatment was well tolerated. No dose-limiting toxicities (DLTs) were observed, and the most common serious adverse events were associated with lymphodepleting chemotherapy and/or disease progression. Various parameters, such as measurable clinical responses in two patients, the occurrence of CRS in two additional patients, and reductions in PRAME mRNA levels in bone marrow (BM) or peripheral blood (PB) in seven patients, served as signs of the clinical and biological activity of MDG1011 TCR-T therapy.
Patients enrolled in the phase 1 part of CD-TCR-001 displayed signs of potential clinical and biological activity of MDG1011 among the small number of patients studied. Advanced disease stage and rapid progression in the r/r AML patients limited clinical impact. The acceptable safety profile of MDG1011 merits further investigation of this TCR-T therapy, potentially in patients at an earlier stage of their disease and with lower tumor burden.
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