Mont-Saint-Guibert, Belgium; February 18, 2025, 7:00 am CET –

蒙特-圣吉贝尔，比利时；2025年2月18日，早上7:00（欧洲中部时间）–

Celyad Oncology (Euronext: CYAD) (the “Company”), today announces the publication of the preclinical data of the non-gene edited allogeneic CYAD-211 and clinical data from the Phase I IMMUNICY-1 clinical study which evaluated CYAD-211 in relapsed or refractory (r/r) multiple myeloma (MM) patients. The findings were published in the .

Celyad Oncology（泛欧交易所代码：CYAD）（“公司”）今天宣布了非基因编辑同种异体CYAD-211的临床前数据以及评估CYAD-211在复发或难治性（r/r）多发性骨髓瘤（MM）患者中的I期IMMUNICY-1临床研究的临床数据。这些研究结果发表在 。

International Journal of Molecular Science (IJMS)

国际分子科学杂志 (IJMS)

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CYAD-211 is the Company’s first allogeneic chimeric antigen receptor (CAR) T-cell candidate, engineered to co-express a B-cell maturation antigen (BCMA)-specific CAR and a microRNA-based single shRNA which interferes with the expression of the CD3ζ component of the T-cell receptor (TCR) complex, evaluated clinically..

CYAD-211是该公司首个同种异体嵌合抗原受体（CAR）T细胞候选产品，经过工程改造，共表达一种B细胞成熟抗原（BCMA）特异性CAR和一种基于微小RNA的单链shRNA，后者可干扰T细胞受体（TCR）复合体中CD3ζ成分的表达，并已进入临床评估。

The IJMS publication includes preclinical data which showcases the knockdown of CD3ζ efficiently removed the TCR complex from the cell surface, and inhibited TCR mediated activation

《国际分子科学杂志》发表的内容包括临床前数据，展示了CD3ζ的敲除能有效去除细胞表面的TCR复合物，并抑制TCR介导的激活。

in vitro

体外

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in vivo

体内

. The publication also presents clinical data of the dose-escalation segment of the IMMUNICY-1 phase-I clinical trial (NCT04613557) in patients with r/r MM.  Importantly, data highlighted an overall good safety profile and some clinical responses, with no signs of graft-versus-host disease (GvHD), demonstrating the effectiveness and safeness of the technology to abrogate the risk of GvHD..

该出版物还介绍了IMMUNICY-1一期临床试验（NCT04613557）中针对复发/难治性多发性骨髓瘤（r/r MM）患者的剂量递增阶段的临床数据。重要的是，数据显示总体安全性良好，并有一些临床反应，且未出现移植物抗宿主病（GvHD）的迹象，证明了该技术在消除GvHD风险方面的有效性和安全性。

Overall, these data provides the proof-of-concept of the safe administration of CAR T-cells engineered using a miRNA-based shRNA technology. CYAD-211 is the first allogeneic CAR T-cell candidate using a non-gene edited approach to achieve allogenicity. This differentiated strategy provides key advantages by being easily implemented, safe, efficient, tunable, and with the possibility to modulate multiple target genes simultaneously..

总体而言，这些数据提供了使用基于miRNA的shRNA技术构建的CAR T细胞安全应用的概念验证。CYAD-211是首个使用非基因编辑方法实现异体化的同种异体CAR T细胞候选产品。这一差异化策略具有显著优势，包括易于实施、安全性高、效率高、可调节性强，并且能够同时调控多个目标基因。

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