Pilot Study of Emapalumab With Post-Transplant Cyclophosphamide as Graft-Versus-Host Disease Prophylaxis for Reduced-Intensity Allogeneic Hematopoietic Cell Transplantation

This phase I trial tests the safety, side effects and effectiveness of emapalumab with post-transplant cyclophosphamide, tacrolimus, and mycophenolate mofetil in preventing graft-versus-host disease (GVHD) in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) after reduced-intensity donor (allogeneic) hematopoietic cell transplant (HCT). Giving chemotherapy, such as fludarabine, melphalan, or busulfan, before a donor [peripheral blood stem cell] transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. When healthy stem cells for a donor are infused into a patient (allogeneic HCT), they may help the patient's bone marrow make more healthy cells and platelets. Allogeneic HCT is an established treatment, however, GVHD continues to be a major problem of allogeneic HCT that can complicate therapy. GVHD is a disease caused when cells from a donated stem cell graft attack the normal tissue of the transplant patient. Emapalumab binds to an immune system protein called interferon gamma. This may help lower the body's immune response and reduce inflammation. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid and may kill cancer cells. It may also lower the body's immune response. Tacrolimus is a drug used to help reduce the risk of rejection by the body of organ and bone marrow transplants. Mycophenolate mofetil is a drug used to prevent GVHD after organ transplants. It is also being studied in the prevention of GVHD after stem cell transplants for cancer, and in the treatment of some autoimmune disorders. Mycophenolate mofetil is a type of immunosuppressive agent. Giving emapalumab with post-transplant cyclophosphamide, tacrolimus and mycophenolate mofetil may be safe, tolerable and/or effective in preventing GVHD in patients with AML or MDS after a reduced-intensity allogeneic HCT.

开始日期2026-05-25

申办/合作机构

City of Hope National Medical Center

[+1]

NCT06694701

/ Recruiting临床2期IIT

Emapalumab Treatment For Anticipated Clinical Benefit In Sepsis Driven By The Interferon-Gamma Endotype (The EMBRACE Trial)

EMBRACE is a double-blind, randomized, placebo-controlled, phase IIa study that will be conducted in multiple Intensive Care Units (ICUs) and departments of Internal Medicine across Greece. It aims to investigate if treatment with emapalumab, a monoclonal antibody which blocks IFNγ, may improve the outcome of patients with sepsis driven by the IDS (endotype of IFNγ-driven sepsis) endotype. EMBRACE also aims to identify the best dosing regimen of emapalumab for the management of IDS.

开始日期2025-03-22

申办/合作机构

Hellenic Institute for the Study of Sepsis

NCT06550141

/ Recruiting临床2期IIT

A Phase 2 Trial of Emapalumab for the Prevention of CAR-T Cell Associated Toxicities

This research study involves assessing the impact of emapalumab as preventative management of CAR-T related cytokine release syndrome in participants with Non-Hodgkin's lymphoma (NHL).
The research study involves the following study interventions:
* Fludarabine and cyclophosphamide (Lymphodepleting Chemotherapy)
* Axicabtagene Ciloleucel
* Emapalumab

开始日期2024-09-18

申办/合作机构

The Massachusetts General Hospital

[+1]

100 项与依马利尤单抗相关的临床结果

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100 项与依马利尤单抗相关的转化医学

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100 项与依马利尤单抗相关的专利（医药）

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项与依马利尤单抗相关的文献（医药）

2025-05-01·ANNALS OF THE RHEUMATIC DISEASES

Refractory MDA-5 dermatomyositis rapidly progressive interstitial lung disease successfully treated with emapalumab

Letter

作者: Concepcion, Jennifer ; Corbitt, Kelly ; Vehar, Susan ; Marti, Miriam

2025-04-01·CLINICAL RHEUMATOLOGY

Salvage treatment of AOSD-associated macrophage activation syndrome with bariticinib following conventional immunosuppressive therapy

Article

作者: Xiang, TianDan ; Xu, Ying ; Sun, Wei ; Huang, Xiaoping ; Huang, Yan ; Zhou, Jin ; Yin, Yufeng ; Li, Wenting ; Xu, Chuancai ; Wang, Yan

OBJECTIVES:

Adult-onset Still's disease (AOSD)-associated macrophage activation syndrome (MAS) is a highly inflammatory condition. Currently, the main treatment method for AOSD-associated MAS is high-dose glucocorticoid shock therapy, but the effect is not satisfactory, and new therapeutic methods or drugs are urgently needed. The aim of this study was to evaluate the efficacy and safety of salvage baricitinib therapy for AOSD-associated MAS following conventional immunosuppressive therapy.

METHOD:

Data from nine patients with MAS treated in the Department of Infection and the Department of Rheumatology, First Affiliated Hospital of Soochow University, from January 2020 to December 2022, were retrospective analysed. Salvage therapy with baricitinib was administered, with an initial dose of 8 mg/day. The patients' clinical symptoms and MAS indices (blood counts and triglyceride, fibrinogen, lactate dehydrogenase, sCD25, and Fer levels) were observed. After a complete response was achieved, the baricitinib dose was gradually reduced to 2-4 mg/day and maintained.

RESULTS:

The MAS blood test results of all nine patients improved to varying degrees within 1 week post-treatment. The MAS indices gradually returned to normal approximately 8 weeks after discharge; at the 12-month outpatient follow-up, seven patients did not develop MAS again, but two patients (patients 5 and 9) had MAS recurrence. The follow-up period ended with salvage treatment with emapalumab.

CONCLUSIONS:

Baricitinib can effectively inhibit the inflammatory response and improve outcomes in the treatment of MAS secondary to rheumatic immunity-related diseases; moreover, this drug treatment is safe. Our study provides a new strategy for MAS salvage therapy. Key Points • Bariticinib may be a palliative treatment option for recurrent/refractory MAS.

2025-04-01·RHEUMATOLOGY

Acute respiratory distress syndrome after emapalumab treatment in a child with severe Still’s disease and lung involvement: a case report

Article

作者: Despert, Véronique ; Koné-Paut, Isabelle ; Rossi-Semerano, Linda ; Anselmi, Federica ; Dusser, Perrine ; Terzic, Arnaud

项与依马利尤单抗相关的新闻（医药）

2025-06-12

·sobi.com

Sobi share new clinical data across multiple hematologic diseases at EHA 2025

Sobi® (STO: SOBI) will present data at the 30th EHA (European Haematology Association) hybrid congress, in Milan, Italy (12-15 June). The congress will feature the latest advances in the treatment of diffuse large B-cell lymphoma (DLBCL), immune thrombocytopenia (ITP), myelofibrosis, paroxysmal nocturnal haemoglobinuria (PNH), and primary hemophagocytic lymphohistiocytosis (pHLH). An extensive programme of poster presentations will showcase Sobi’s commitment to helping patients with rare diseases by advancing treatment options. In addition, Sobi will host several scientific symposiums at the congress including: 1.Advancing Therapeutic Knowledge in Paroxysmal Nocturnal Haemoglobinuria: Reshaping disease management to unlock new norms, Thursday, 12 June, 10:00am - 11:30am CEST, at Amber Hall 3 & 4. 2. Boosting Platelets: Expert Approaches to Adult Immune Thrombocytopenia (ITP), Saturday 14 June, 8.00 am - 9.30 am CEST, at Amber Hall 7 & 8. 3. Dissecting Treatment Sequencing in relapsed/refractory DLBCL, from laboratory to real life. Saturday, 14 June, 8:00 am – 9:30 am, CEST at Coral Hall 1. “The breadth of data that we share at this year’s EHA congress demonstrates Sobi’s comprehensive approach to addressing rare conditions in haematology. We are proud to contribute to advancing the science in several indications from early clinical phases in diffuse large B-cell lymphoma to clinical and real-world evidence in myelofibrosis, primary hemophagocytic lymphohistiocytosis, immune thrombocytopenia and paroxysmal nocturnal haemoglobinuria,” said Lydia Abad-Franch, MD, Head of R&D and Medical Affairs, and Chief Medical Officer at Sobi. Key data to be presented at EHA 2025 DLBCL PS1911: Initial Results From LOTIS-7: A Phase 1b Study of Loncastuximab Tesirine Plus Glofitamab in Patients With Relapsed/Refractory (R/R) Diffuse Large BCell Lymphoma (DLBCL) Presenting Author: Juan Pablo Alderuccio Poster presentation Session title: Poster Session 2Session date: Saturday, 14 June Session time: 18:30-19:30 CEST Location: Poster Hall PS1957: Updated Safety Run-in Results from LOTIS-5: A Phase 3, Randomized Trial of Loncastuximab Tesirine with Rituximab Versus Immunochemotherapy in Patients With R/R DLBCL Presenting Author: Carmelo Carlo-Stella Immune Thrombocytopenia (ITP) PF1236: Platelet Response to Avatrombopag Among Patients with Primary Immune Thrombocytopenia Who Switched from Eltrombopag or Romiplostim: the REAL-AVA 2.0 Real-World Study Presenting Author: Shruti Chaturvedi Poster presentation Session title: Poster Session 1Session date: Friday, 13 June Session time: 18:30 - 19:30 CEST Location: Poster Hall PF1239: Durability of Response to Avatrombopag Among Patients with Primary Immune Thrombocytopenia: The REAL-AVA 2.0 Real-World Study Presenting Author: Srikanth Nagalla PF1251: Clinically Meaningful Response to Avatrombopag: A Phase 3B Trial for Treatment of Children with ITP Presenting Author: Rachael F. Grace PS2231: Effectiveness and safety of avatrombopag for the treatment of adults with newly diagnosed, persistent, or chronic immune thrombocytopenia: Interim results from the phase 4 ADOPT study Presenting Author: Waleed Ghanima Poster presentation Session title: Poster Session 2Session date: Saturday, 14 June Session time: 18:30 - 19:30 CEST Location: Poster Hall PS2234: Efficacy and safety of avatrombopag for the treatment of pediatric immune thrombocytopenia in the open-label extension of a phase 3, randomized, double-blind, placebo-controlled trial Presenting Author: Rachael F. Grace PS2239: Real-World Treatment Patterns & Clinical Outcomes in Thrombopoietin Receptor Agonist Naive Patients with Immune Thrombocytopenia Treated with Avatrombopag: Interim Results from the REAL-AVA 3.0 Study Presenting Author: Sandhya Panch PS2242: Effectiveness and safety of avatrombopag for treatment of immune thrombocytopenia in older patients and those with comorbidities or prior TPO-RA exposure: Interim results from the phase 4 ADOPT study Presenting Author: María Eva Mingot-Castellano PS2244: Response to Avatrombopag Among Patients with Chronic and Persistent Primary Immune Thrombocytopenia: the REAL-AVA 2.0 Real-World Study Presenting Author: M Y Levy PS2250: Evaluation of Efficacy and Safety of Avatrombopag in Children with Immune Thrombocytopenia based on Disease Duration: Results from the Avatrombopag Phase 3-b Pediatric Trial Presenting Author: Rachael F. Grace PB3676: Baseline Correlates with Durability of Avatrombopag Response: A Phase 3B Trial for Treatment of Children with ITP Publication Only Published on May 14 at 15:30 CEST PB3684: Consistent Response to Avatrombopag across Various Baseline Characteristics: Results from the Phase 3-b Trial for the Treatment of Children with Immune Thrombocytopenia Myelofibrosis PF849: Hematologic improvement experienced by pacritinib-treated patients with myelofibrosis in real-world clinical settings Presenting Author: Michael Marrone Poster presentation Session title: Poster Session 1Session date: Friday, 13 June Session time: 18:30 - 19:30 CEST Location: Poster Hall PF1242: Efficacy of pacritinib vs momelotinib in patients with thrombocytopenic MF: a matched adjusted indicated treatment comparison Presenting Author: Koo Wilson PF1306: Transfusion-related cost and time burden offsets in patients with myelofibrosis treated with pacritinib compared to best available therapy based on PERSIST-2 trial Presenting Author: Abiola Oladapo PS1827: Real-world effectiveness of pacritinib in patients with myelofibrosis who have concurrent thrombocytopenia and anemia Presenting Author: Raajit Rampal Poster presentation Session title: Poster Session 2 Session date: Saturday, 14 June Session time: 18:30-19:30 CEST Location: Poster Hall PS1842: Real-World Treatment Patterns and Clinical Outcomes in Patients with Myelofibrosis Treated with Pacritinib (PAC) with platelets ≥50 x109/L at PAC initiation: Interim results from the MY-PAC Study Presenting Author: Doug Tremblay PS2295: Economic Burden of Cytopenia in Patients with Myelofibrosis: Analysis of a US National Administrative Claims Database Presenting Author: Lucia Marasova PB3079: Cytopenia is associated with real-world disease progression and diminished survival in patients with myelofibrosis: Analysis of a US national administrative claims database Publication Only Published on May 14 at 15:30 CEST Paroxysmal Nocturnal Hemoglobinuria PF672: Early response in complement inhibitor naïve patients with paroxysmal nocturnal hemoglobinuria treated with pegcetacoplan in the Phase 3 PRINCE trial Presenting Author: Austin Kulasekararaj Poster presentation Session title: Poster Session 1Session date: Friday, 13 June Session time: 18:30 - 19:30 CEST Location: Poster Hall PF676: Interim analysis of the ongoing COMPLETE study on the real-world effectiveness of pegcetacoplan in patients with paroxysmal nocturnal hemoglobinuria (PNH) Presenting Author: Regis Peffault de Latour PS1662: A benefit assessment of pegcetacoplan dose increase in the Phase 3 PEGASUS trial of PNH patients with difficult-to-control disease Presenting Author: Morag Griffin Poster presentation Session title: Poster Session 2Session date: Saturday, 14 June Session time: 18:30 - 19:30 CEST Location: Poster Hall PS1665: Benefit of pegcetacoplan in patients with paroxysmal nocturnal hemoglobinuria irrespective of baseline transfusion status Presenting Author: Britta Höchsmann Primary Hemophagocytic Lymphohistiocytosis (pHLH) PF1036: Emapalumab in patients with primary hemophagocytic lymphohistiocytosis: Efficacy and safety outcomes from a multinational, open-label, single-arm study Presenting Author: Franco Locatelli Poster presentation Session title: Poster Session 1Session date: Friday, 13 June Session time: 18:30 - 19:30 CEST Location: Poster Hall About pegcetacoplan in rare diseases Pegcetacoplan is a targeted C3 therapy designed to regulate excessive activation of the complement cascade, a part of the body’s immune system, which can lead to the onset and progression of many serious diseases. Pegcetacoplan is under investigation for rare diseases across haematology and nephrology. Pegcetacoplan is approved for the treatment of paroxysmal nocturnal haemoglobinuria (PNH) as EMPAVELI®/Aspaveli® in the United States, European Union, and other countries globally About Doptelet® (avatrombopag) Doptelet® (avatrombopag) is indicated for the treatment of primary chronic immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments, and a treatment of severe thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo an invasive procedure. About Zynlonta® (loncastuximab tesirine)Zynlonta® (loncastuximab tesirine) is a CD19-directed antibody drug conjugate (ADC). Zynlonta as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy. About Sobi® Sobi is a global biopharma company unlocking the potential of breakthrough innovations, transforming everyday life for people living with rare diseases. Sobi has approximately 1,900 employees across Europe, North America, the Middle East, Asia and Australia. In 2024, revenue amounted to SEK 26 billion. Sobi’s share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com and LinkedIn. Contacts For details on how to contact the Sobi Investor Relations Team, please click here. For Sobi Media contacts, click here. We provide access to innovative treatments that transform life for people. Our therapies are concentrated within the areas of Haematology, Immunology and Specialty Care. We contribute to societies by improving access to treatment of rare diseases. Every day, we work actively to find better ways to understand and meet patient needs. Find out more about our business and financial performance. Here we present current and past media releases, images and videos.

临床3期免疫疗法临床结果上市批准临床1期

2025-03-19

·PRNewswire

Sobi announces a new research collaboration on the development of Gamifant® (emapalumab) in sepsis, which is to be presented at the ISICEM congress

STOCKHOLM, March 19, 2025 /PRNewswire/ -- Sobi ® (STO: SOBI), today announced a research collaboration involving a new Phase 2a clinical trial for Gamifant® (emapalumab) for the potential treatment of interferon-gamma (IFNγ)-driven sepsis (IDS) which is to be presented at the International Symposium on Intensive Care and Emergency Medicine (ISICEM) Congress by Prof. Giamarellos-Bourboulis, from the Hellenic Institute for the Study of Sepsis. The study underscores Sobi's commitment to advancing medicine through targeted therapies for severe and complex conditions such as sepsis, a leading cause of mortality globally. Key Highlights IDS is a new endotype representing approximately 20 percent of sepsis patients and is characterised by detection of IFNγ (above lower limit of detection) and elevated levels of the chemokine CXCL9. The EMBRACE phase 2a study will investigate the potential of Gamifant® (emapalumab) in treating a subgroup of sepsis patients driven by the IDS endotype and absence of sepsis-induced immunoparalysis. IDS patients with a low human leukocyte antigen DR (HLA-DR) expression on monocytes characteristic of immunoparalysis will not be included into the EMBRACE study. The potential inclusion of this IDS sub-population into further studies will be evaluated based on the results of EMBRACE. The EMBRACE phase 2a trial (NCT06694701) was approved in March 2025. The first trial sites have been initiated, and patient screening to identify eligible patients with IDS has started. The trial design is to be presented at ISICEM by Prof. Evangelos Giamarellos-Bourboulis, MD, PhD, FISAC, principal investigator and sponsor of the EMBRACE study, from the Hellenic Institute for the Study of Sepsis (HISS): "The EMBRACE Phase 2a study will adopt a precision immunotherapy approach for the treatment of sepsis driven by the IDS endotype, a patient group currently having limited therapeutic choices." "We are looking forward to this research collaboration on the use of Gamifant® (emapalumab) in the new endotype of interferon gamma-driven sepsis," said Lydia Abad-Franch, MD, Head of Research & Development and Medical Affairs and Chief Medical Officer at Sobi. "We are committed to advancing science and study Gamifant® (emapalumab) in indications with a high unmet need and where excessive interferon gamma production plays a key role in driving hyperinflammation." Presentation details Emapalumab treatment for anticipated clinical benefit in sepsis driven by the interferon-gamma endotype (the EMBRACE trial): O Konstantinidou, E Olntasi, H Florou, A Reininger, E Giamarellos-Bourboulis, F EMBRACE STUDY GROUP. ISICEM 2025; Abstract number A173; Poster number P249. About sepsis and IFNγ-driven sepsis (IDS) Sepsis is a serious condition in response to an infection that can lead to organ failure and is a leading global cause of mortality. A recent large study, published in eBioMedicine in 20241, describes different sepsis endotypes, suggesting varying endotypes require differentiated treatment strategies. Approximately 20% of the patients studied are of the newly described IFNγ-driven sepsis (IDS) endotype. IDS is marked by elevated levels of CXCL9 and detection of IFNγ and poor clinical outcomes, with a 28-day mortality rate ranging from 40 to 43%. About the EMBRACE study The EMBRACE study (NCT06694701) is a Phase 2a, double-blind, randomized controlled trial planned to be conducted at 24 sites in Greece. The trial investigates whether Gamifant® (emapalumab), an anti-IFNγ antibody, can improve clinical outcomes in patients with the interferon-gamma-driven sepsis (IDS) endotype and absence of sepsis-induced immunoparalysis. IDS is characterized by elevated levels of CXCL9 and detectable IFNγ and is associated with poor patient outcomes. By targeting this inflammation pathway, the EMBRACE trial aims to reduce mortality, improve organ function, and accelerate recovery. The trial design includes three arms, and plans to enrol 75 patients, two groups receiving Gamifant® (emapalumab), (low and high doses) alongside standard-of-care treatment, and one group receiving placebo alongside standard-of-care treatment. The primary endpoint is a ≥1.4-point decrease in the Sequential Organ Failure Assessment (SOFA) score from baseline to the end of treatment (28 days). Secondary endpoints include 28-day mortality, safety, pharmacokinetics, and changes in key inflammatory biomarkers such as CRP, IL-6, ferritin, IFNγ, and CXCL9. About Gamifant® (emapalumab) Gamifant® (emapalumab) is an anti-interferon gamma (IFNγ) monoclonal antibody that binds to and neutralises IFNγ. In the USA, Gamifant® (emapalumab) is indicated for the treatment of adult and paediatric (newborn and older) patients with primary haemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. Primary HLH is a rare syndrome of hyperinflammation that usually occurs within the first year of life and can rapidly become fatal unless diagnosed and treated. The FDA approval is based on data from the phase 2/3 studies (NCT01818492 and NCT02069899). Gamifant® (emapalumab) is indicated for administration through intravenous infusion over one hour twice per week until haematopoietic stem cell transplantation (HSCT) About Sobi® Sobi® is a specialised international biopharmaceutical company transforming the lives of people with rare and debilitating diseases. Providing reliable access to innovative medicines in the areas of haematology, immunology, and specialty care. Sobi has approximately 1,800 employees across Europe, North America, the Middle East, Asia, and Australia. In 2024, revenue amounted to SEK 26 billion. Sobi's share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com and LinkedIn. 1: Interferon-gamma driven elevation of CXCL9: a new sepsis endotype independently associated with mortality Giamarellos-Bourboulis, Evangelos J. et al. eBioMedicine, Volume 109, 105414 Contacts For details on how to contact the Sobi Investor Relations Team, please click here. For Sobi Media contacts, click here. This information was brought to you by Cision The following files are available for download: WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床2期上市批准免疫疗法

2025-02-28

·Pharmaceutical Technology

FDA accepts Sobi’s Gamifant application for HLH/MAS treatment

Sobi’s Gamifant was previously approved by the US regulator in 2018. © Swedish Orphan Biovitrum AB. The US Food and Drug Administration has accepted Sobi’s supplemental biologics licence application for Gamifant (emapalumab-Izsg) for haemophagocytic lymphohistiocytosis (HLH)/macrophage activation syndrome (MAS) associated with Still’s disease. The application, which seeks approval for use in both adult and paediatric individuals who show an insufficient response or are not tolerant to glucocorticoids, or with recurrent MAS, has received priority review status. A Prescription Drug User Fee Act date was set by the agency for 27 June 2025. The sBLA is supported by pooled data outcomes from the EMERALD and NI-0501-06 studies, which enrolled a total of 39 subjects. 53% of subjects achieved a complete response by week 8 and 85% at any time during the studies. Sobi chief medical officer and research and development head Lydia Abad-Franch stated: “HLH/MAS in Still’s disease is a serious and potentially fatal complication where patients can experience intense hyperinflammation and even multiple organ failure. “Gamifant (emapalumab-Izsg) selectively neutralises interferon-gamma (IFN-γ), a key driver of hyperinflammation, and if approved, may also help reduce the need for high-dose glucocorticoids in these patients.” The therapy was previously approved by the US regulator in 2018 to treat primary HLH in adult and paediatric patients, including newborns, with refractory, recurrent or progressive conditions, or those who are not tolerant to conventional HLH therapies. A critical complication of rheumatic conditions, HLH/MAS is most commonly observed in Still’s disease, including systemic juvenile idiopathic arthritis and adult-onset Still’s disease. It is marked by severe inflammation, presenting with symptoms such as persistent high fever, elevated levels of ferritin, cytopenias, hepatosplenomegaly and coagulopathies. The company received marketing authorisation from the European Commission in June 2024 for Altuvoct (efanesoctocog alfa), a treatment designed for haemophilia A patients to manage bleeds and provide perioperative prophylaxis.

上市批准临床结果优先审批申请上市

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外链

KEGG	Wiki	ATC	Drug Bank
-	依马利尤单抗	L04AA39	DB14724

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
噬血细胞性淋巴组织细胞增多症	美国	NovImmune SA	2018-11-20

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
巨噬细胞活化综合征	申请上市	美国	Swedish Orphan Biovitrum AB	2025-02-27
免疫系统疾病	申请上市	欧盟	Swedish Orphan Biovitrum AB	2020-07-23
多关节型幼年特发性关节炎	临床3期	美国	苏庇医药（广州）有限公司	2022-01-14
多关节型幼年特发性关节炎	临床3期	日本	苏庇医药（广州）有限公司	2022-01-14
多关节型幼年特发性关节炎	临床3期	比利时	苏庇医药（广州）有限公司	2022-01-14
多关节型幼年特发性关节炎	临床3期	加拿大	苏庇医药（广州）有限公司	2022-01-14
多关节型幼年特发性关节炎	临床3期	捷克	苏庇医药（广州）有限公司	2022-01-14
多关节型幼年特发性关节炎	临床3期	法国	苏庇医药（广州）有限公司	2022-01-14
多关节型幼年特发性关节炎	临床3期	德国	苏庇医药（广州）有限公司	2022-01-14
多关节型幼年特发性关节炎	临床3期	意大利	苏庇医药（广州）有限公司	2022-01-14

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


PS2153 (EHA2025)	N/A	细胞因子释放综合征 IFN-γ \| TNF-α \| IL-2 ... 更多	38	Emapalumab	範獵鏇夢衊襯觸衊襯觸(糧製鑰窪襯選鹹顧網壓) = 8 patients died (2 from disease relapse/progression, 4 from severe infections, and 2 from septic shock associated with CRS) 獵壓淵網膚範憲製餘襯 (鹹鹹壓網鑰繭淵夢糧壓 ) 更多	积极	2025-05-14
Tandem Meetings ASTCT and CIBMTR2024	N/A	-	-	Emapalumab	獵憲衊構網觸窪憲獵鑰(觸積壓衊窪鑰獵淵憲餘) = 積壓廠繭壓蓋夢壓憲簾餘襯夢構積膚範膚夢醖 (鹽鑰糧遞糧壓廠鏇蓋網 )	-	2024-02-01
NCT04765553 (CTgov)	临床1期	罕见病	8	NI-0501 (Emapalumab)	鹹鏇製築廠憲築鹽遞顧(觸廠鑰艱窪齋艱簾夢膚) = 膚衊鬱繭獵鏇積艱遞蓋網鏇網窪範醖襯衊積鬱 (鬱鏇蓋淵顧艱積鏇餘構, 醖簾廠築夢構構製膚醖 ~ 蓋顧遞憲選淵鑰艱遞糧) 更多	-	2023-11-24
NCT04765553 (CTgov)	临床1期	罕见病	8	Saline (Placebo)	壓鑰網淵夢糧醖範糧壓 = 觸糧繭觸壓製構簾蓋鑰遞製鏇鏇鬱窪齋選範壓 (獵積觸鑰醖壓膚遞衊觸, 獵獵齋鑰蓋膚積觸顧構 ~ 鑰鑰餘壓鹽顧願網繭襯) 更多	-	2023-11-24
NCT03985423 (CTgov)	临床2/3期	噬血细胞性淋巴组织细胞增多症	7	Emapalumab-Lzsg	壓窪觸願夢襯膚窪鏇簾(糧鹹獵遞夢顧遞選顧鹽) = 簾鏇範壓夢觸淵鏇選醖糧衊製鹹憲衊壓築願鏇 (醖夢襯鏇窪衊淵鹽壓觸, 壓鑰範夢顧夢襯憲齋膚 ~ 壓齋積範壓範壓憲襯膚) 更多	-	2023-10-06
P353 (EBMT2023)	临床2期	IFNÎ³ \| CXCL9	1	Emapalumab 3 mg/kg	築顧鏇醖鏇築獵觸艱餘(觸齋製憲範夢選積獵遞) = 憲簾簾鏇襯鬱蓋製顧衊鹹範衊顧襯廠餘築窪獵 (築願鹹鏇網膚壓觸鬱築 ) 更多	积极	2023-04-23
NCT02069899 (NI-0501-04 and NI-0501-05 \| ###DELETE, CTgov)	临床2/3期	噬血细胞性淋巴组织细胞增多症	58	Emapalumab (Enrolled-04 Cohort)	構膚鏇鹹鏇襯壓觸衊窪 = 艱繭鹽糧窪繭構選構製齋憲襯衊膚餘醖壓艱壓 (網淵艱蓋餘築願繭獵繭, 選鹽鹽獵壓齋艱積艱範 ~ 獵憲窪廠鬱選廠壓獵膚) 更多	-	2022-06-28
NCT02069899 (NI-0501-04 and NI-0501-05 \| ###DELETE, CTgov)	临床2/3期	噬血细胞性淋巴组织细胞增多症	58	emapalumab (Enrolled-06 Cohort)	構膚鏇鹹鏇襯壓觸衊窪 = 膚餘淵範選構網壓餘鏇齋憲襯衊膚餘醖壓艱壓 (網淵艱蓋餘築願繭獵繭, 遞夢簾憲夢糧襯築廠鑰 ~ 廠憲遞繭構夢製糧選遞) 更多	-	2022-06-28
NCT04731298 (P449, EBMT2022)	临床2期	CXCL9	10	Emapalumab	繭鹽顧膚範蓋膚膚鏇鬱(窪鏇廠鹽憲構遞觸醖範) = 憲構鏇範齋獵壓觸蓋襯觸壓膚範鑰襯窪壓窪蓋 (構築鏇鹹糧醖醖築襯觸 ) 更多	积极	2022-03-19
NCT02069899 \| NCT01818492 (Tandem Meetings ASTCT and CIBMTR2021)	临床2/3期	噬血细胞性淋巴组织细胞增多症二线	45	Emapalumab 1 mg/kg	壓鹽製顧簾鑰蓋壓願築(遞鑰鏇願製製鑰壓積壓) = 鹹壓鏇壓憲積觸選獵範鏇壓鏇構鬱簾憲膚膚夢 (顧膚糧襯襯顧壓範餘窪, 68.3 ~ 97.6) 更多	积极	2021-03-01
	临床2/3期	噬血细胞性淋巴组织细胞增多症二线	45	Background dexamethasone 5-10 mg/m2	壓鹽製顧簾鑰蓋壓願築(遞鑰鏇願製製鑰壓積壓) = 鹽艱顧觸鹽蓋壓齋簾窪鏇壓鏇構鬱簾憲膚膚夢 (顧膚糧襯襯顧壓範餘窪, 62.1 ~ 92.1) 更多	积极	2021-03-01
NCT02069899 \| NCT01818492 (NI-0501-04 \| NI-0501-05, Pubmed \| Br Dent J \| N Engl J Med) 人工标引	临床2/3期	噬血细胞性淋巴组织细胞增多症一线	34	Emapalumab (previously treated)	糧簾糧襯鑰衊淵願淵夢(製衊繭鑰窪夢糧窪艱醖) = 衊範壓鏇築蓋獵鹽憲衊簾遞糧蓋餘膚壓顧淵壓 (醖壓醖壓廠窪鑰顧鏇觸 ) 更多	积极	2020-05-07
	临床2/3期	噬血细胞性淋巴组织细胞增多症一线	34	Emapalumab (previously untreated)	糧簾糧襯鑰衊淵願淵夢(製衊繭鑰窪夢糧窪艱醖) = 壓願網夢廠觸繭鹹鹹願簾遞糧蓋餘膚壓顧淵壓 (醖壓醖壓廠窪鑰顧鏇觸 ) 更多	积极	2020-05-07
NI-0501 (ACR2015)	N/A	噬血细胞性淋巴组织细胞增多症 IFNg	10	NI-0501 1 mg/kg	製蓋顧膚積夢觸築夢製(構選築壓憲範繭餘醖願) = All infusions were well tolerated and no safety concerns emerged 選觸獵醖鏇獵壓憲選積 (淵構鑰構鹽憲艱膚選鹹 )	积极	2015-11-10