肿瘤细胞治疗研究
英文原题：Phase I Trial of MCARH109, a G Protein-Coupled Receptor Class C Group 5 Member D (GPRC5D)-Targeted Chimeric Antigen Receptor T-Cell Therapy for Multiple Myeloma: An Updated Analysis.
Phase I Trial of MCARH109, a G Protein-Coupled Receptor Class C Group 5 Member D (GPRC5D)-Targeted Chimeric Antigen Receptor T-Cell Therapy for Multiple Myeloma: An Updated Analysis.
这项 I 期临床试验纳入 17 例患者，确定 MCARH109 在 150×10⁶ CAR-T 细胞的最大耐受剂量下是安全的。
MCARH109是一种首创的、靶向G蛋白偶联受体C类5组D型（GPRC5D）的嵌合抗原受体（CAR）T细胞疗法，用于治疗复发/难治性多发性骨髓瘤。该I期临床试验纳入17例患者，确定MCARH109在最大耐受剂量1.5×10⁸个CAR-T细胞时安全。在本次更新分析中，中位随访37个月时未报告新的严重不良事件。17例中有12例（71%）应答，其中既往接受靶向B细胞成熟抗原治疗的10例患者中有7例（70%）应答。中位应答持续时间为8.6个月（95% CI：5.7个月至未达到）；截至末次随访，有2例患者仍维持严格完全缓解，分别已持续32个月和41个月。中位总生存期（OS）尚未达到，估算3年OS率为59%（95% CI：40–88）。免疫组化显示，10例复发患者中有6例（60%）可能发生GPRC5D丢失。高维光谱流式细胞术免疫分析发现，单采时T细胞活化表型与MCARH109治疗应答相关。
MCARH109 is a first-in-class G protein-coupled receptor, class C, group 5, member D (GPRC5D)-targeted chimeric antigen receptor (CAR) T-cell therapy for patients with relapsed/refractory multiple myeloma. This phase I clinical trial included 17 patients and determined that MCARH109 is safe at a maximum tolerated dose of 150 10 6 CAR T cells. In this updated analysis, no new serious adverse events were reported at a median follow-up of 37 months. Overall, 12 (71%) of 17 patients responded, including seven (70%) of 10 patients previously treated with B-cell maturation antigen-targeted therapy. The median duration of response was 8.6 months (95% CI, 5.7 to not reached [NR]) with two patients sustaining a stringent complete response at the time of last follow-up, 32 months and 41 months, respectively. The median overall survival (OS) was NR and the 3-year OS estimate was 59% (95% CI, 40 to 88). Possible GPRC5D loss via immunohistochemistry was observed in 6 (60%) of 10 patients at relapse. High-dimensional spectral cytometry-based immune profiling associated an activated T-cell phenotype at apheresis with a response to MCARH109.
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