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更新于：2026-11-03
Lumrotatug
更新于：2026-11-03
概要
基本信息
原研机构 |
最高研发阶段临床2期 |
首次获批日期- |
最高研发阶段(中国)临床2期 |
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结构/序列
Sequence Code 1034096165H
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Sequence Code 1034096166L
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关联
14
项与 Lumrotatug 相关的临床试验NCT07910903
A Randomized, Open-Label, Multicenter, Phase 3 Study To Compare the Efficacy and Safety of CM336 + CM313 Combination Therapy Versus Daratumumab + Pomalidomide +Dexamethasone (DPd) in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received 1 to 3 Prior Lines of Therapy
NCT06663943
A Prospective, Single-Center, Open-Label, Randomized Clinical Study on the Treatment of Pemphigus With a Novel Humanized CD38 Monoclonal Antibody (CM313)
NCT06830395
A Phase II Clinical Study to Evaluate the Safety and Efficacy of CM313 (SC) Injection in Subjects With Primary IgA Nephropathy
100 项与 Lumrotatug 相关的临床结果
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100 项与 Lumrotatug 相关的专利（医药）
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6
项与 Lumrotatug 相关的文献（医药）2025-09-01CTS-Clinical and Translational Science
Pharmacokinetics, Pharmacodynamics, and Immunogenicity of
CM313
in Healthy Participants: An Open‐Label/Double‐Blind, Randomized, Placebo‐Controlled Phase 1 Trial
Article
作者: Zhao, Junxue ; He, Jinjie ; Zhang, Jing ; Chen, Bo ; Hou, Qiaoyun ; Song, Han ; Wu, Junzhen ; Yan, Hongyue ; Zhang, Xiang ; Yu, Shuyan ; Yang, Yifan ; Qiu, Yanping ; Xue, Yu ; Guo, Bujing
ABSTRACT:
CM313, a novel humanized anti‐CD38 monoclonal antibody, has demonstrated therapeutic potential in autoimmune diseases. This Phase 1 trial evaluated safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy participants following single ascending doses of CM313. Fifty‐one participants received CM313 or placebo by SC injection at doses of 150 mg (1:1), 300 mg (2:1), and 600 mg (2:1), or by IV infusion at 8 mg/kg (2:1). All completed the trial. Treatment‐emergent adverse events occurred in 90.9% of CM313‐treated participants and 83.3% of placebo‐treated participants, all mild or moderate. No serious adverse events were reported. SC injections of CM313 demonstrated a notably lower incidence of infusion‐related reactions (600 mg SC: 20%) than IV infusion (8 mg/kg IV: 60%). CM313 exhibited nonlinear pharmacokinetics. Following a single SC dose, the median
Tmax
was 2.00–3.00 days, mean
Cmax
was 4.75–87.40 μg/mL, mean AUC
0‐
t
was 20.29–1262.50 day*μg/mL, mean
Vz
/
F
was 2.63–21.20 L, mean clearance was 0.50–7.90 L/day, and mean half‐life was 1.85–3.90 days. The bioavailability of the 600 mg SC dose was 66% of the 8 mg/kg IV dose. CM313 induced rapid and sustained reductions in total IgA, IgE, IgG, and IgM levels by 40%–80% from baseline. Both SC and IV formulations demonstrated potent CD38 binding activity and markedly depleted NK cells by ≥ 90% within 2 days. CM313 also achieved 80%–90% CD38 receptor occupancy on B cells, T cells, and monocytes within 1 week. Overall, single doses of CM313 demonstrated favorable safety, tolerability, PK, and PD in healthy participants.
Trial Registration:ClinicalTrials.gov
(NCT06285227)
2025-03-01AMERICAN JOURNAL OF HEMATOLOGY
Letter
作者: An, Gang ; Qin, Ling ; Bao, Li ; Zhou, Huixing ; Fang, Baijun ; Huang, Zhongxia ; Li, Ling ; Li, Xin ; Jing, Hongmei ; Liu, Yuzhang ; Cai, Zhen ; Wang, Yanrong ; Song, Yuqin ; Chen, Wenming ; Xia, Zhongjun
Multiple myeloma (MM) accounts for approximately one-tenth of all hematological malignancies. Although immunomodulatory drugs (IMiDs) and proteasome inhibitors (PIs) have significantly prolonged survival of MM patients, relapses are almost inevitable [1]. Patients refractory to IMiDs and PIs have a poor prognosis, highlighting the urgency to develop new agents with target specificity in patients with relapsed/refractory MM (RRMM). CD38 is a type 2 transmembrane glycoprotein highly expressed in hematological malignancies and low in normal tissues, permitting CD38-targeting antibody a novel therapeutic option for RRMM. Currently, two anti-CD38 monoclonal antibodies, daratumumab and isatuximab, have been approved for the treatment of RRMM [2-4]. CM313 is a novel humanized monoclonal antibody with a unique complementarity-determining region sequence that facilitates its high affinity to a spectrum of CD38-positive cells. Preclinical studies showed its comparable in vitro killing activities in target cells and anti-tumor activities with daratumumab, without obvious off-target toxicity [5]. CM313 also demonstrated encouraging efficacy and favorable safety in patients with immune thrombocytopenia [6]. Here, we report the first-in-human phase 1 trial of CM313 monotherapy in patients with RRMM and marginal zone lymphoma (MZL). This was a multicenter, open-label phase 1 trial consisting of a dose-escalation phase and a dose-expansion phase (NCT04818372). Eligible RRMM patients had a confirmed diagnosis of MM based on the International Myeloma Working Group guidelines, measurable disease, an Eastern Cooperative Oncology Group performance-status score of ≤ 2 points, and prior treatment with IMiDs and PIs. Key exclusion criteria were primary refractory MM, diagnosis of amyloidosis, plasma-cell leukemia, or polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, skin changes (POEMS) syndrome, confirmed central nervous system metastases, and prior therapy with anti-CD38 monoclonal antibodies. Detailed eligibility criteria for RRMM and MZL patients are presented in the Supporting Information. Patients in the dose-escalation phase received 9 escalating doses of CM313 intravenously (0.006, 0.06, 0.3, 1.0, 2.0, 4.0, 8.0, 16, and 24 mg/kg) once in a 21-day observation period for dose-limiting toxicities (DLTs), then once weekly (QW) for the next 7 doses, then every 2 weeks (Q2W) for 8 doses, and then every 4 weeks (Q4W) onwards until disease progression or unacceptable toxicities. In the dose-expansion phase, CM313 was administered intravenously at doses of 4.0 and 16 mg/kg QW for 8 doses, then Q2W for 8 doses, and then Q4W thereafter until disease progression or unacceptable toxicities (Figure S1A). Primary endpoints were safety and tolerability in the dose-escalation phase and overall response rate (ORR) in the dose-expansion phase. Secondary endpoints included clinical benefit rate (CBR), time to response, duration of response (DOR), progression-free survival (PFS), overall survival (OS), pharmacokinetics, pharmacodynamics, and immunogenicity. The study design and procedures are detailed in the Supporting Information. Between April 15, 2021 and August 3, 2023, 41 patients with RRMM and three with MZL were enrolled in this trial. As of the end of the study (April 3, 2024), 6 patients remained on treatment and 38 had discontinued treatment due to disease progression (n = 31 [70.5%]), subject's decision (n = 4 [9.1%]), or investigator's decision (n = 3 [6.8%]) (Figure S1B). In RRMM patients, median time since diagnosis was 4.4 years (range 0.9–10.3) and patients had received a median of 3 (range 2–10) lines of prior therapies. All 41 RRMM patients had previously received PIs and IMiDs (Table S1). Baseline demographic and disease characteristics of MZL patients are presented in Table S2. No DLTs were reported up to 24 mg/kg and the maximum tolerated dose was not reached. Thirty-two infusion-related reactions (IRRs) were reported in 59.1% (26/44) of patients and were of grade 1 or 2, except for one patient with RRMM in the 1.0 mg/kg cohort who experienced a grade 3 reaction during the first infusion. IRRs occurred in 59.1% (26/44) of patients during the first infusion and in 12.5% (5/40) of patients during subsequent infusions (Figure S2). All IRRs resolved either spontaneously or with treatment, with a median duration of 1.5 h (range 0.0–151.4). The most common treatment-emergent adverse events (TEAEs), excluding IRRs, were white blood cell count decreased (47.7%) and lymphocyte count decreased (43.2%) (Table S3). Twenty-five (56.8%) patients reported grade ≥ 3 TEAEs and 19 (43.2%) patients reported grade ≥ 3 drug-related TEAEs. Ten (22.7%) patients reported serious adverse events (SAEs) and 6 (13.6%) patients reported drug-related SAEs. There were no TEAEs leading to permanent treatment discontinuation. One patient in the 16 mg/kg cohort experienced one TEAE leading to death (respiratory failure) which was deemed unrelated to the study drug. Grade 2 COVID-19 was reported in this patient 3 days before he died. The median follow-up was 19.4 months (range 3.6–36.5) for all enrolled patients and 19.3 months (range 4.5–36.5) for RRMM patients. A waterfall plot of percent changes in paraprotein is shown in Figure 1A. The ORR was 36.6% (15/41, 95% confidence interval [CI] 22.1%–53.1%) in all RRMM patients and 44.4% (8/18, 95% CI 21.5%–69.2%) in the 16 mg/kg dose cohort. The CBR was 46.3% (19/41, 95% CI 30.7%–62.6%) in all RRMM patients and 50.0% (9/18, 95% CI 26.0%–74.0%) in the 16 mg/kg dose cohort (Table S4). In patients who had a response to treatment, the median time to response was 0.9 months (range 0.5–2.8) and DOR was 16.4 months (95% CI 6.6-NR). In patients responding to 16 mg/kg of CM313, the median time to response was 1.3 months (range 0.9–2.8) and the median DOR was 16.4 months (range 3.7-NR) (Figure S3 and Table S4). The median PFS was 4.3 months (95% CI 2.3–8.5) in all RRMM patients and 4.6 months (95% CI 2.0–17.9) in the 16 mg/kg cohort (Figure 1B and Table S4). The median OS was not reached (95% CI 19.5-NR). The 12-month and 24-month OS rates were 80.5% (95% CI 64.8%–89.7%) and 60.5% (95% CI 41.6%–75.0%) in all RRMM patients, respectively, and 88.9% (95% CI 62.4%–97.1%) and 67.3% (95% CI 36.6%–85.6%) in the 16 mg/kg cohort, respectively (Figure 1C and Table S4). Treatment responses and survival of MZL patients are presented in Table S5. CM313 exposure, as measured by the maximum observed serum concentration and area under the concentration-time curve, increased in a greater than dose-proportional manner (Figure S4 and Table S6). The elimination of CM313 appeared to be nonlinear and time-varying. Mean elimination half-life increased and clearance decreased with increasing doses and multiple doses (Table S6). Receptor occupancy (CD3+ T cell, CD14+ monocyte, and CD19+ B cell) reached 60%–100% at 2 h after a single dose and maintained high during the treatment (Figure S5). Peripheral blood NK cell (total and CD38+) counts of RRMM patients decreased by 80%–100% compared to baseline in all dose groups in the dose-escalation and dose-expansion phases (Figure S6). All patients in this trial were negative for treatment-related anti-drug antibody. This first-in-human study showed that CM313 monotherapy was well tolerated and displayed encouraging efficacy in patients with RRMM who had a median of three lines of prior therapy. IRRs and other TEAEs were generally tolerable and manageable. RRMM patients achieved rapid (median time to response, 0.9 months), deep (24.4% with VGPR or better), and durable (median DOR, 16.4 months) responses with CM313 monotherapy. Median PFS was 4.3 months and median OS was not reached, with a 12-month OS rate of 80.5%. CM313 showed favorable safety and tolerability. IRRs were reported in 59.1% of all enrolled patients and were manageable through peri-infusion medications or by lowering the infusion rate and other symptomatic treatment in this study. The most common TEAEs excluding IRRs were hematological, consistent with daratumumab and isatuximab [3, 4]. SAEs were reported in 22.7% of all enrolled patients and in 25.0% of the 16 mg/kg cohort in this study, compared to 33%–48.9% with daratumumab 16 mg/kg [2, 3] and 43% with isatuximab 10–20 mg/kg [4]. No TEAEs leading to permanently treatment discontinuation were reported, indicating that CM313 was tolerated in RRMM patients. No new safety signal was identified. With an innovative complementarity-determining region molecular structure, CM313 may differ in reorganization and interaction with epitopes compared to other anti-CD38 monoclonal antibodies. Preclinical studies showed comparable anti-tumor activity of CM313 with daratumumab [5]. In this study, ORR was 36.6% in all RRMM patients and 44.4% in the 16 kg/mg cohort, comparable to the ORR in RRMM patients receiving daratumumab 16 kg/mg (36%–42.6%) [2, 3] and isatuximab 10 kg/mg or higher (23.8%) [4]. Median DOR was 16.4 months in the present study, similar to 18.9 months obtained in Chinese RRMM patients receiving daratumumab 16 kg/mg [3]. Median PFS in this study was 4.3 months for all RRMM patients and 4.6 months for the 16 kg/mg cohort, comparable to daratumumab and isatuximab in the aforementioned phase 1–2 trials (2.9–6.7 months) [2-4]. The median OS in this study was not reached; the 12-month OS rate were 80.5% in the total population and 88.9% in the 16 kg/mg subgroup, similar to those of daratumumab and isatuximab monotherapy in the above trials (69.8%–78.1%) [2, 3]. Further follow-up will provide mature OS data. In conclusion, CM313 monotherapy demonstrated a manageable safety profile and promising clinical efficacy in patients with RRMM or MZL. A multi-center phase 1/2 study is underway to evaluate the efficacy and safety of CM313 subcutaneous injections in RRMM patients (NCT06126237). All authors report substantial contributions to the conception and design of the studies, acquisition of data, or the analysis or interpretation of data; have critically reviewed the manuscript; approved the final version; agree with all content; and agree to be accountable for all aspects of the work. The authors would like to thank the patients and their families for participating in this study and acknowledge the contributions of all investigators and study site staff to the study. All participants signed written informed consents before enrollment. The consent forms were approved by the ethics committee at each trial site. Yanrong Wang and Ling Li are employees of Keymed Biosciences (Chengdu) Co., Ltd. All other authors declare no conflicts of interest. The datasets generated and analyzed during this study are available from the corresponding author upon reasonable request. Data S1. Please note: The publisher is not responsible for the content or functionality of any supporting information supplied by the authors. Any queries (other than missing content) should be directed to the corresponding author for the article.
2024-06-20NEW ENGLAND JOURNAL OF MEDICINE
A Novel Anti-CD38 Monoclonal Antibody for Treating Immune Thrombocytopenia
Article
作者: Chen, Yunfei ; Cao, Xuan ; Wang, Wentian ; Ma, Yueshen ; Yang, Renchi ; Liu, Xiaofan ; Li, Huiyuan ; Wang, Yuhua ; Liu, Wei ; Dai, Xinyue ; Xue, Feng ; Sun, Ting ; Chi, Ying ; Pei, Xiaolei ; Zhang, Lei ; Ju, Mankai ; Song, Zhen ; Dong, Huan ; Gu, Wenjing ; Fu, Rongfeng ; Xu, Yanmei
BACKGROUND:
Immune thrombocytopenia (ITP) is an autoimmune disease characterized by autoantibody-mediated platelet destruction. Treatment with CM313, a novel anti-CD38 monoclonal antibody, can result in targeted clearance of CD38-positive cells, including plasma cells.
METHODS:
We conducted a phase 1-2, open-label study to evaluate the safety and efficacy of CM313 in adult patients with ITP. CM313 was administered intravenously at a dose of 16 mg per kilogram of body weight every week for 8 weeks, followed by a 16-week follow-up period. The primary outcomes were adverse events and documentation of two or more consecutive platelet counts of at least 50×109 per liter within 8 weeks after the first dose of CM313. The status of peripheral-blood immune cells in patients and changes in the mononuclear phagocytic system in passive mouse models of ITP receiving anti-CD38 therapy were monitored.
RESULTS:
Of the 22 patients included in the study, 21 (95%) had two consecutive platelet counts of at least 50×109 per liter during the treatment period, with a median cumulative response duration of 23 weeks (interquartile range, 17 to 24). The median time to the first platelet count of at least 50×109 per liter was 1 week (range, 1 to 3). The most common adverse events that occurred during the study were infusion-related reaction (in 32% of the patients) and upper respiratory tract infection (in 32%). After CD38-targeted therapy, the percentage of CD56dimCD16+ natural killer cells, the expression of CD32b on monocytes in peripheral blood, and the number of macrophages in the spleen of the passive mouse models of ITP all decreased.
CONCLUSIONS:
In this study, anti-CD38 targeted therapy rapidly boosted platelet levels by inhibiting antibody-dependent cell-mediated cytotoxicity on platelets, maintained long-term efficacy by clearing plasma cells, and was associated with mainly low-grade toxic effects. (Funded by the Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences and others; ClinicalTrials.gov number, NCT05694767).
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研发状态
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 免疫球蛋白a肾病 | 临床2期 | 中国 | 2025-03-24 | |
| 再生障碍性贫血 | 临床2期 | 中国 | 2025-02-18 | |
| 免疫性血小板减少症 | 临床2期 | 中国 | 2024-11-01 | |
| 难治性多发性骨髓瘤 | 临床2期 | - | 2024-02-28 | |
| 多发性骨髓瘤 | 临床2期 | 中国 | 2024-01-17 | |
| 系统性红斑狼疮 | 临床2期 | - | 2022-10-30 | |
| 血液肿瘤 | 临床1期 | 中国 | 2021-04-15 | |
| 复发性多发性骨髓瘤 | 临床1期 | 中国 | 2021-04-15 |
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临床结果
临床结果
适应症
分期
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临床1/2期 | 40 | 艱糧膚構選膚醖衊遞鏇(襯夢膚構範構窪顧網夢) = 顧顧鹹餘鬱鏇廠觸選獵 築獵繭廠鹽願衊願製積 (繭憲夢壓顧醖簾糧鹽齋 ) 更多 | 积极 | 2025-11-26 | |||
願醖齋鏇遞繭簾製鹽淵(築淵廠衊醖膚艱築築網) = 襯齋窪夢醖範膚鏇窪獵 醖繭艱蓋積窪範製鹽艱 (襯鏇艱窪範膚衊網鹹獵 ) | |||||||
临床2期 | 45 | 簾積艱築艱窪糧膚鹽糧(網鑰願糧餘築築獵壓餘) = 夢觸簾積簾選蓋願餘窪 觸鬱獵餘網顧鑰繭廠膚 (範壓廠製遞繭齋鹽糧簾 ) 更多 | 积极 | 2025-10-21 | |||
Placebo | 簾積艱築艱窪糧膚鹽糧(網鑰願糧餘築築獵壓餘) = 網襯鹹築鏇遞淵廠襯網 觸鬱獵餘網顧鑰繭廠膚 (範壓廠製遞繭齋鹽糧簾 ) 更多 | ||||||
临床2期 | 45 | 糧願築餘憲醖蓋憲觸襯(積蓋齋廠糧餘觸鬱製糧) = 鹽遞鑰夢網遞構顧鹽衊 膚衊餘淵願襯壓製夢願 (廠淵夢鬱餘選顧廠餘糧, 33.7 ~ 81.3) | 积极 | 2025-06-03 | |||
Placebo | 糧願築餘憲醖蓋憲觸襯(積蓋齋廠糧餘觸鬱製糧) = 簾鏇齋簾範憲齋製積鏇 膚衊餘淵願襯壓製夢願 (廠淵夢鬱餘選顧廠餘糧 ) | ||||||
临床1/2期 | 22 | 艱糧願衊鬱築襯獵窪繭(淵膚窪願願膚衊壓廠築) = The most common that occurred during the study were infusion-related reaction (in 32% of the patients) and upper respiratory tract infection (in 32%). 築憲襯鏇遞鬱鹹網餘壓 (衊鬱夢選淵範鏇獵蓋蓋 ) | 积极 | 2024-06-19 | |||
临床2期 | 21 | 鏇餘獵醖構衊夢衊糧膚(齋遞網鹹鏇觸艱顧鹽醖) = 6 (6/21, 28.6%) had an infusion-related reaction (IRR) at the first dose but none at subsequent doses. The severity of IRR was grade 1 or 2 (according to CTCAE version 5.0) 範獵窪簾鏇積構繭醖顧 (鏇鑰齋憲壓鑰鹽鑰憲壓 ) | 积极 | 2023-12-09 | |||
临床1期 | 34 | 餘蓋鏇蓋衊淵襯顧夢繭(衊醖齋鹽齋艱網製壓蓋) = Grade 3 or higher treatment-emergent adverse events (TEAEs) were reported in 15/34 (44.1%) pts (8 [23.5%] were considered drug related); there were no grade 5 TEAEs 膚鏇選壓醖獵繭壓繭醖 (衊積構網齋選積醖獵淵 ) 更多 | - | 2023-06-08 |
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