Evidence map›Paper›PMID 41290616›Full record

Trial reportSignal transduction and targeted therapy2025

Anti-CD38 monoclonal antibody CM313 for systemic lupus erythematosus: a randomized, double-blind, placebo-controlled phase Ib/IIa trial.

Jiuliang Zhao, Changsong Lin, Qibing Xie, Qiang Shu, Yang Cui, Hui Luo, Wenqiang Fan, Anbin Huang, Yi Zhao, Zili Fu and 13 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Signal transduction and targeted therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05465707 (A Randomized, Double-blind, Placebo-controlled, Dose-escalation, Multiple-dose Phase Ib/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Efficacy of CM313 Injection in Subjects With Systemic Lupus Erythematosus), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

NCT05465707 phase1 / phase2unknown statusnot on this map

A Randomized, Double-blind, Placebo-controlled, Dose-escalation, Multiple-dose Phase Ib/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Efficacy of CM313 Injection in Subjects With Systemic Lupus Erythematosus

TypeinterventionalSponsorKeymed Biosciences Co.LtdRan2022 to 2023Enrolled40ConditionsSystemic Lupus ErythematosusArmsCM313 2 mg/kg, CM313 4 mg/kg, CM313 8 mg/kg, CM313 16 mg/kg, Placebo
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
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

23 authors.

Jiuliang ZhaoDepartment of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, China.
Changsong LinDepartment of Rheumatology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China.
Qibing XieDepartment of Rheumatology and Immunology, West China Hospital of Sichuan University, Chengdu, Sichuan, China.
Qiang ShuDepartment of Rheumatology and Immunology, Qilu Hospital of Shandong University, Jinan, Shandong, China.
Yang CuiDepartment of Rheumatology, Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China.
Hui LuoDepartment of Rheumatology and Immunology, Xiangya Hospital, Central South University, Changsha, Hunan, China.
Wenqiang FanDepartment of Rheumatology and Immunology, Xinxiang Central Hospital, The Fourth Clinical College of Xinxiang Medical University, Xinxiang, Henan, China.
Anbin HuangDepartment of Rheumatology and Immunology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.
Yi ZhaoDepartment of Rheumatology & Allergy, Xuanwu Hospital Capital Medical University, Beijing, China.
Zili FuDepartment of Rheumatology and Immunology, The First Hospital of Shanxi Medical University, Taiyuan, Shanxi, China.
Changhao XieDepartment of Rheumatology and Immunology, The First Affiliated Hospital of Bengbu Medical University, Bengbu, Anhui, China.
Huaxiang WuDepartment of Rheumatology, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.ORCID 0000-0002-5052-7519
Niansheng YangDepartment of Rheumatology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China.
Lan HeDepartment of Rheumatology and Immunology, The First Affiliated Hospital of Xi'An Jiao Tong University, Xi'An, Shaanxi, China.
Ping FengClinical Trial Center, National Medical Products Administration Key Laboratory for Clinical Research and Evaluation of Innovative Drugs, West China Hospital of Sichuan University, Chengdu, Sichuan, China.
Tiandong ZhangDrug Clinical Trial Instituti, Xinxiang Central Hospital, The Fourth Clinical College of Xinxiang Medical University, Xinxiang, Henan, China.
Huan ZhouPhase I Center, The First Affiliated Hospital of Bengbu Medical University, Bengbu, Anhui, China.
Wei LiuKeymed Biosciences (Chengdu) Co., Ltd, Chengdu, Sichuan, China.
Qiaoyun HouKeymed Biosciences (Chengdu) Co., Ltd, Chengdu, Sichuan, China.
Xihua MaoKeymed Biosciences (Chengdu) Co., Ltd, Chengdu, Sichuan, China.
Jing SunKeymed Biosciences (Chengdu) Co., Ltd, Chengdu, Sichuan, China.
Bo ChenKeymed Biosciences (Chengdu) Co., Ltd, Chengdu, Sichuan, China.
Xiaofeng ZengDepartment of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, China. zengxfpumc@163.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

CD38 is highly expressed on various immune cells, including long-lived plasma cells, making it a potential therapeutic target in autoimmune diseases. This phase Ib/IIa study aimed to explore the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of CM313, an anti-CD38 antibody, in patients with systemic lupus erythematosus (SLE). Eligible patients were sequentially enrolled in four ascending dose groups (2, 4, 8, and 16 mg/kg) and randomized 4:1 to receive CM313 or placebo intravenously at days 1, 29, 36, 43, and 50. The primary endpoint was safety, and efficacy was exploratorily investigated. Between October 14, 2022, and March 7, 2024, 40 patients were enrolled, including 8 patients in each CM313 dose group and the pooled placebo group. Adverse events occurred in 90.6% and 62.5% of participants receiving CM313 and placebo, all of which were mild or moderate. Upper respiratory tract infection (87.5%/62.5% vs. 12.5%), urinary tract infection (12.5%/25.0% vs. 0), and herpes zoster (25.0%/0 vs. 0) were more frequent in CM313 8 and 16 mg/kg groups than the placebo group. The CM313 groups had greater reductions in anti-ds-DNA antibodies, immunoglobulin G (IgG), IgA, IgM, IgE, and greater increases in complement C3 and C4 compared with placebo. Systemic Lupus Erythematosus Responder Index-4 response rates were 33.3%, 40.0%, 62.5%, 71.4%, and 37.5% in CM313 2, 4, 8, 16 mg/kg, and placebo groups at day 57, respectively. CM313 showed a manageable safety profile in SLE patients at 2-16 mg/kg and encouraging clinical efficacy at 8 and 16 mg/kg. The results support further investigation of CM313 for treating SLE patients (ClinicalTrials.gov ID: NCT05465707).

Indexed as

ADP-ribosyl Cyclase 1Antibodies, MonoclonalAntibodies, Monoclonal, HumanizedLupus Erythematosus, SystemicAdultDouble-Blind MethodFemaleHumansMaleMembrane GlycoproteinsMiddle AgedADP-ribosyl Cyclase 1Antibodies, MonoclonalAntibodies, Monoclonal, HumanizedCD38 protein, humanMembrane Glycoproteins

Identifiers

PMID41290616
PMCPMC12647876

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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.