Tifcemalimab as monotherapy or in combination with toripalimab in patients with relapsed/refractory lymphoma: a Phase I trial

Yuqin Song, Jun Ma, Huilai Zhang, Yan Xie, Zhigang Peng, Yuerong Shuang, Fei Li, Yufu Li, Haiyan Yang, Liqun Zou, Xiuhua Sun, Weili Zhao, Wenrong Huang, Yunhong Huang, Hui Zhou, Yifan Wang, Weiwei Wang, Jing Xu, Rong Deng, Qin Meng and Jun Zhu ()
Additional contact information
Yuqin Song: Peking University Cancer Hospital & Institute
Jun Ma: Harbin Institute of Hematology & Oncology
Huilai Zhang: Tianjin Medical University Cancer Institute and Hospital
Yan Xie: Peking University Cancer Hospital & Institute
Zhigang Peng: The First Affiliated Hospital of Guangxi Medical University
Yuerong Shuang: Jiangxi Cancer Hospital
Fei Li: The First Affiliated Hospital of Nanchang University
Yufu Li: Henan Cancer Hospital
Haiyan Yang: Zhejiang Cancer Hospital
Liqun Zou: West China Hospital of Sichuan University
Xiuhua Sun: The Second Hospital of Dalian Medical University
Weili Zhao: Shanghai Jiaotong University School of Medicine
Wenrong Huang: The Fifth Medical Center of the General Hospital of the Chinese People’s Liberation Army
Yunhong Huang: The Affiliated Cancer Hospital of Guizhou Medical University
Hui Zhou: Hunan Cancer Hospital
Yifan Wang: Shanghai Junshi Biosciences
Weiwei Wang: Shanghai Junshi Biosciences
Jing Xu: Shanghai Junshi Biosciences
Rong Deng: Shanghai Junshi Biosciences
Qin Meng: Shanghai Junshi Biosciences
Jun Zhu: Peking University Cancer Hospital & Institute

Nature Communications, 2025, vol. 16, issue 1, 1-9

Abstract: Abstract Preclinical studies of tifcemalimab (anti-BTLA antibody) in combination with toripalimab (anti-PD-1 antibody) demonstrated synergistic anti-tumor effects. We present the outcomes of tifcemalimab with or without toripalimab in lymphoma patients. This is a 2-part, phase I study (NCT04477772). In Part A (dose escalation based on 3 + 3 design), patients with relapsed or refractory lymphoma received tifcemalimab monotherapy 1, 3 or 10 mg/kg for dose escalation and 3 mg/kg or 200 mg for dose expansion. For Part B (indication expansion), only classical Hodgkin’s lymphoma (cHL) patients were included to receive tifcemalimab 100 or 200 mg plus toripalimab 240 mg due to poor tumor response in other subtypes. The primary endpoints were safety, maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D). 25 patients in Part A and 46 in Part B were enrolled. No dose-limiting toxicities were observed, and MTD was not reached. The RP2D for tifcemalimab was 200 mg. Adverse events were predominantly Grade 1/2. Grade 3/4 treatment-related adverse events occurred in 3 patients (12·0%) in Part A and 15 patients (32·6%) in Part B. No fatal adverse events were observed. Tifcemalimab with or without toripalimab demonstrated a favorable safety profile in lymphoma patients.

Date: 2025
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DOI: 10.1038/s41467-025-59461-3

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