Orca-T: First Approval

doi:10.1007/s40291-026-00882-1

2026-09-17

PRE

Hannah A. Blair *

DOI：10.1007/s40291-026-00882-1

原文链接

原文求助

摘要

En 中文

同种异基因调节性T细胞免疫疗法与造血干细胞和祖细胞（HSPC）及T细胞-vldq（以下简称Orca-T，TREGZI™）是由Orca Bio在斯坦福大学许可下开发的，用于预防慢性移植物抗宿主病（cGVHD）。2026年6月30日，Orca-T在美国首次获批，用于与匹配供体造血干细胞移植（HSCT）结合大剂量预处理方案，以促进造血和免疫重建并改善cGVHD-free生存期，治疗成人血液恶性肿瘤。本文总结了Orca-T在预防cGVHD方面的开发里程碑，直至获得首次批准。

期刊

Molecular Diagnosis & Therapy

IF:

4.4

论文数:

被引数:

机构

暂无机构信息

引用论文

Quantitative Analysis of Thymus-Independent Donor-Derived T Cell Expansion in Transplant Patients

Biology of Blood and Marrow Transplantation

IF0

2020-02-01

OAAI

Xiaoyue Gao; Chen Xu; Botao Li; Long Zhao; Yingying Yu; Yongfeng Su; Jun Wang; Na Liu; Jianlin Chen; Jiangwei Hu; Sanchun Lan; Yuhang Li; Zhiyong Yu; Xiao Lou; Hongmei Ning; Min Jiang; Liangding Hu; Tao Sun; Bin Zhang; Hu Chen

Orca-T versus allogeneic hematopoietic stem cell transplantation (PRECISION-T): a multicenter, randomized phase 3 trial Orca-T与异基因造血干细胞移植（PRECISION-T）：一项多中心、随机III期试验

Blood

IF23.1

2025-12-16

OAAI

Everett H. Meyer; Amandeep Salhotra; Arpita P. Gandhi; Jeremy Pantin; Sagar S. Patel; Rasmus T. Hoeg; Alexandra Gomez-Arteaga; Rawan Faramand; Roni Tamari; Edmund K. Waller; Satyajit Kosuri; Antonio M. Jimenez Jimenez; Jennifer Holter-Chakrabarty; Bhagirathbhai Dholaria; Yi-Bin Chen; Betty K. Hamilton; John Magenau; Alireza Eghtedar; Joshua M. Murray; Anna Pavlova

Regulatory T Cell Therapy of Graft-versus-Host Disease: Advances and Challenges

International Journal of Molecular Sciences

IF0

2021-09-07

OAAI

Mehrdad Hefazi; Sara Bolivar-Wagers; Bruce R. Blazar

Donor regulatory T-cell therapy to prevent graft-versus-host disease 供者调节性T细胞疗法预防移植物抗宿主病

BLOOD

IF23.1

2025-01-10

OAAI

Meyer, Everett H.; Pavlova, Anna; Xie, Bryan; Kim, Paige; Sutherland, Katherine; Bharadwaj, Hma; Dahiya, Saurabh; Frank, Matthew; Arai, Sally; Johnston, Laura; Miklos, David; Rezvani, Andrew; Shiraz, Parveen; Sidana, Surbhi; Shizuru, Judy; Weng, Wen-Kai; Agrawal, Vaibhav; Putnam, Amy; Fernhoff, Nathaniel; Tamarisis, John; Mcclellan, J. Scott; Lowsky, Robert; Negrin, Robert S.

Allogeneic HSC and regulatory T cell (Orca-T) engineered cell therapy following reduced intensity conditioning: Results of a single center Phase 1 study 异基因HSC和调节性T细胞（Orca-T）工程化细胞疗法在降低强度预处理后的应用：一项单中心1期研究的结果

Blood

IF0

2025-11-03

PREAI

Villar-Prados,Alejandro; Kim,Paige; Sutherland,Katherine; Negrin,Robert; Arai,Sally; Frank,Matthew; Johnston,Laura; Lowsky,Robert; Miklos,David; Muffly,Lori; Dahiya,Saurabh; Rezvani,Andrew; Sidana,Surbhi; Shiraz,Parveen; Shizuru,Judith; Weng,Wen-Kai; Smith,Melody; Bharadwaj,Sushma; Tamaresis,John; Pavlova,Anna; McClellan,J. Scott; Meyer,Everett

Regulatory T cell therapy for Graft-versus-Host Disease 调节性T细胞疗法治疗移植物抗宿主病

BONE MARROW TRANSPLANTATION

IF5.2

2025-04-16

OAAI

Lysandrou, Memnon; Kefala, Dionysia; Vinnakota, Janaki Manoja; Savvopoulos, Nikolaos; Spyridonidis, Alexandros

T cell immune reconstitution following lymphodepletion

SEMINARS IN IMMUNOLOGY

IF7.8

2007-10-01

300

OAAI

Williams, Kirsten A.; Hakim, Frances T.; Gress, Ronald E.

Therapeutic use of regulatory T cells for graft‐versus‐host disease

British Journal of Haematology

IF0

2019-08-16

OAAI

Shlomo Elias; Alexander Y. Rudensky

Single-center randomized trial of T-reg graft alone vs T-reg graft plus tacrolimus for the prevention of acute GVHD

BLOOD ADVANCES

IF7.1

2024-02-28

OAAI

Bader, Cameron S.; Pavlova, Anna; Lowsky, Robert; Muff, Lori S.; Shiraz, Parveen; Arai, Sally; Johnston, Laura J.; Rezvani, Andrew R.; Weng, Wen-Kai; Miklos, David B.; Frank, Matthew J.; Tamaresis, John S.; Agrawal, Vaibhav; Bharadwaj, Sushma; Sidana, Surbhi; Shizuru, Judith A.; Fernhoff, Nathaniel B.; Putnam, Amy; Killian, Scott; Xie, Bryan J.; Negrin, Robert S.; Meyer, Everett H.

Single Center phase 1b Study of Orca-T Following Escalated Doses of Total Marrow and Lymphoid Irradiation (TMLI) in Patients with Acute Leukemia or MDS 单中心1b期研究：在急性白血病或MDS患者中，经剂量递增的全骨髓和淋巴组织照射（TMLI）后使用Orca-T

Transplantation and Cellular Therapy

IF0

2026-02-01

PREAI

Salhotra,Amandeep; Dandapani,Savita; Yang,Dongyun; Mokhtari,Sally; Sahebi,Firoozeh; Agrawal,Vaibhav; Aribi,Ahmed; Sandhu,Karamjeet S.; Koller,Paul; Wong,Jeffrey; Stein,Anthony S.; Marcucci,Guido; Nakamura,Ryotaro; Hui,Susanta; Malki,Monzr M. Al

查看更多内容