Orca-T: First Approval.

IF 5.8 3区医学 Q1 GENETICS & HEREDITY

Molecular Diagnosis & Therapy Pub Date : 2026-09-17 DOI:10.1007/s40291-026-00882-1

Hannah A Blair

引用次数: 0

Abstract

Allogeneic regulatory T cell immunotherapy with haematopoietic stem and progenitor cells (HSPC) and T cells-vldq, hereafter referred to as Orca-T (TREGZI^™), has been developed by Orca Bio under license from Stanford University for the prevention of chronic graft-versus-host disease (cGVHD). On 30 June 2026, Orca-T received its first approval in the USA for use in matched donor haematopoietic stem cell transplantation (HSCT) with myeloablative preparative regimen, for haematopoietic and immunologic reconstitution and to improve cGVHD-free survival, in the treatment of adults with haematological malignancies. This article summarizes the milestones in the development of Orca-T leading to this first approval for the prevention of cGVHD.

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Orca-T：第一次批准。

基于造血干细胞和祖细胞（HSPC）和T细胞-vldq的同种异体调节性T细胞免疫疗法，以下简称Orca-T （TREGZI™），由Orca Bio根据斯坦福大学的许可开发，用于预防慢性移植物抗宿主病（cGVHD）。2026年6月30日，Orca-T在美国首次获得批准，用于配合供体造血干细胞移植（HSCT）的清髓准备方案，用于造血和免疫重建，并提高成人血液系统恶性肿瘤的无cgvhd生存。本文总结了Orca-T在预防cGVHD中首次获批的发展历程。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Molecular Diagnosis & Therapy 医学-药学

CiteScore

7.80

自引率

2.50%

发文量

审稿时长

>12 weeks

期刊介绍： Molecular Diagnosis & Therapy welcomes current opinion articles on emerging or contentious issues, comprehensive narrative reviews, systematic reviews (as outlined by the PRISMA statement), original research articles (including short communications) and letters to the editor. All manuscripts are subject to peer review by international experts.