Evidence map›Paper›PMID 40379637›Full record

ArticleNature communications2025

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 and 11 more

Registry-linked trialAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in Nature communications, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04477772 (A Phase I Clinical Study of Recombinant Humanized Anti-BTLA Monoclonal Antibody), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04477772 phase1completednot on this map

A Phase I Clinical Study of Recombinant Humanized Anti-BTLA Monoclonal Antibody (JS004) in Patients With Recurrent/Refractory Malignant Lymphoma

TypeinterventionalSponsorShanghai Junshi Bioscience Co., Ltd.Ran2020 to 2024Enrolled71ConditionsRecurrent/Refractory Malignant LymphomaArmsJS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion, Drug:JS001, Intravenous infusion
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. MutantFrontiers in immunology · 2026
    Article
  2. Review
  3. Review
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors.

Yuqin Song *Peking University Cancer Hospital & Institute, Beijing, China.
Jun Ma *Harbin Institute of Hematology & Oncology, Harbin, China.
Huilai ZhangTianjin Medical University Cancer Institute and Hospital, Tianjin, China.
Yan XiePeking University Cancer Hospital & Institute, Beijing, China.
Zhigang PengThe First Affiliated Hospital of Guangxi Medical University, Nanning, China.
Yuerong ShuangJiangxi Cancer Hospital, Nanchang, China.
Fei LiThe First Affiliated Hospital of Nanchang University, Nanchang, China.
Yufu LiHenan Cancer Hospital, Zhengzhou, China.
Haiyan YangZhejiang Cancer Hospital, Hangzhou, China.
Liqun ZouWest China Hospital of Sichuan University, Chengdu, China.
Xiuhua SunThe Second Hospital of Dalian Medical University, Dalian, China.
Weili ZhaoShanghai Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
Wenrong HuangThe Fifth Medical Center of the General Hospital of the Chinese People's Liberation Army, Beijing, China.
Yunhong HuangThe Affiliated Cancer Hospital of Guizhou Medical University, Guiyang, China.
Hui ZhouHunan Cancer Hospital, Changsha, China.
Yifan WangShanghai Junshi Biosciences, Shanghai, China.
Weiwei WangShanghai Junshi Biosciences, Shanghai, China.
Jing XuShanghai Junshi Biosciences, Shanghai, China.
Rong DengShanghai Junshi Biosciences, Shanghai, China.
Qin MengShanghai Junshi Biosciences, Shanghai, China.
Jun ZhuPeking University Cancer Hospital & Institute, Beijing, China. zhu-jun2017@outlook.com.ORCID http://orcid.org/0000-0003-3479-2547

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsHodgkin DiseaseLymphomaAdultAgedFemaleHumansMaleMaximum Tolerated DoseMiddle AgedTreatment OutcomeAntibodies, Monoclonal, Humanizedtoripalimab

Identifiers

PMID40379637
PMCPMC12084519

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.