Liposomal mitoxantrone plus tislelizumab in patients with relapsed or refractory extranodal natural killer/T-cell lymphoma: a phase 1b/2 trial.

Authors

Qihua Zou, Shenrui Bai, Liang Wang, Hongyan Tong, Dongfeng Zeng, Ying Zhao, Yuerong Shuang, Xiaobo Wang, Xiuhua Sun, Zhenya Hong, Zhigang Peng, Yu Yang, Runhui Zheng, Huiqiang Huang, Jianbo Liu, Chunmei Yang, Xi Li, Xin Gao, Hao Xu, Daoguang Chen, Xiaojie Fang, Man Nie, Jinni Wang, Xinna Gao, Jingjing Ye, Wei Zhang, Jianzhen Shen, Rong Tao, Hong Cen, Yuchen Zhang, Jun Cai, Yi Xia, Qingqing Cai

Published in

Nature communications. Jun 15, 2026. Epub Jun 15, 2026.

Abstract

Treatment options for relapsed or refractory extranodal natural killer/T-cell lymphoma (R/R ENKTL) remain limited. In this phase 1b/2 trial (NCT05464433), we evaluated the safety and efficacy of liposomal mitoxantrone (Lipo-MIT) plus anti-PD-1 tislelizumab in this setting. During dose escalation, patients received Lipo-MIT (16 or 20 mg/m²) plus tislelizumab using a 3 + 3 design, followed by dose expansion at the recommended phase 2 dose (RP2D). The primary endpoint of the dose-escalation phase was dose-limiting toxicities (DLTs), which were assessed to determine the RP2D. The primary efficacy endpoint of the dose-expansion phase was the best complete response (CR) rate. Between July 23 2022 and November 28 2024, 40 patients received study treatment (dose-escalation, n = 6; dose-expansion, n = 34). No DLTs were observed and the RP2D of Lipo-MIT was 20 mg/m². The prespecified primary efficacy endpoint was met, with a CR rate of 53% (21/40; one-sided 95% lower confidence bound, 38%). The median progression-free survival (secondary endpoint) was 8.2 months (95% confidence interval, 6.1-not estimable) after a median follow-up of 15.3 months. The most common grade ≥ 3 adverse events were leukopenia (53%), neutropenia (40%), and febrile neutropenia (18%). In conclusion, Lipo-MIT plus tislelizumab showed promising anti-tumor activity with an acceptable safety profile in R/R ENKTL.

PMID:
42297808
Bibliographic data and abstract were imported from PubMed on 16 Jun 2026.

Read full publication at:
Please sign in to see all details.

Stats

1-terrible, 9-excellent. How would you rate this publication? Sign in in to submit your rating.

Post a comment

You need to be signed in to post comments. You can sign in here.

Comments

There are no comments yet.