The Effect of GM-CSF to Preventing Oral Mucositis for Patients With Nasopharyngeal Carcinoma Receiving Radiotherapy: A Single-center, Phase II, Randomized Trial

To evaluate the efficacy of GM-CSF to preventing oral mucositis for patients with nasopharyngeal carcinoma receiving radiotherapy.

开始日期2023-09-15

申办/合作机构

中山大学

100 项与 GM-CSF(Sun Yat-sen University) 相关的临床结果

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100 项与 GM-CSF(Sun Yat-sen University) 相关的专利（医药）

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项与 GM-CSF(Sun Yat-sen University) 相关的文献（医药）

2024-10-01·Molecular Nutrition & Food Research

Garlic Bioconverted by Bacillus subtilis Stimulates the Intestinal Immune System and Modulates Gut Microbiota Composition

Article

作者: Kim, Kwang Bin ; Kim, Hae Soung ; Moon, Sung‐Kwon ; Yu, Hyeonjun ; Kim, Hoon ; Tonog, Genevieve ; Lee, Sanghyun ; Suh, Hyung Joo ; Jeong, Hyeleen

ScopeThis study evaluates the potential of bioconverted garlic ferments (BGFs) to stimulate the intestinal immune system and modulate cecal microbiota composition.Methods and resultsIn vitro, BGF significantly enhances Peyer's patch (PP)‐mediated bone marrow cell proliferation and increases the production of interferon‐gamma (IFN‐γ), granulocyte macrophage‐colony stimulating factor (GM‐CSF), interleukin (IL)‐6, and immunoglobulin A (IgA) but not IL‐4, IL‐5, and immunoglobulin E (IgE). Oral administration of BGF to C3H/HeN mice for 4 weeks significantly increases the GM‐CSF (42.1–45.8 pg mL−1) and IFN‐γ (6.5–12.1 pg mL−1) levels in PP cells. BGF also significantly elevates the levels of tumor necrosis factor‐alpha (TNF‐α, 165.0–236.3 pg mg−1), GM‐CSF (2.4–3.0 ng mg−1), and IFN‐γ (1.5–3.2 ng mg−1) in the small intestinal fluid, and TNF‐α (2.2–3.1 pg mL−1) and IFN‐γ (10.3–0.21.5 pg mL−1) in the mouse serum. Cecal microbial analysis reveals that BGF increases Bacteroidota and Verrucomicrobiota and decreases Actinobacteria and Bacillota at the phylum level in mice. At the genus level, BGF significantly increases the abundance of Fusimonas (250 mg kg−1 BW−1 day−1), Bacteroides (125 and 250 mg kg−1 BW−1 day−1), and Akkermansia (125 mg kg−1 BW−1 day−1) and decreases that of Bifidobacterium (62.5 and 250 mg kg−1 BW−1 day−1) and Limosilactobacillus (125 and 250 mg kg−1 BW−1 day−1).ConclusionThis study provides the first evidence of BGF's ability to modulate the intestinal immune system and gut microbiota, supporting its potential as a novel functional material to enhance gut immunity.

2024-01-01·Journal of Immunology Research

Effects of Injectable Solutions on the Quality of Monocyte‐Derived Dendritic Cells for Immunotherapy

Article

作者: Nosomi Taniwaki, Noemi ; Teodoro Da Silva, Laís ; José da Silva Duarte, Alberto ; Mazzilli Ortega, Marina ; de Jesus Mota, Silvia ; Mitsue Namiyama Nishina, Gislene ; Miyuki Oshiro, Telma ; Tiaki Tiyo, Bruna ; Justamante Handel Schmitz, Gabriela

Therapeutic vaccines based on monocyte‐derived dendritic cells have been shown to be promising strategies and may act as complementary treatments for viral infections, cancers, and, more recently, autoimmune diseases. Alpha‐type‐1‐polarized dendritic cells (aDC1s) have been shown to induce type‐1 immunity with a high capacity to produce interleukin‐12p70 (IL‐12p70). In the clinical use of cell‐based therapeutics, injectable solutions can affect the morphology, immunophenotypic profile, and viability of cells before delivery and their survival after injection. In this sense, preparing a cell suspension that maintains the quality of aDC1s is essential to ensure effective immunotherapy. In the present study, monocytes were differentiated into aDC1s in the presence of IL‐4 and GM‐CSF. On day 5, the cells were matured by the addition of a cytokine cocktail consisting of IFN‐α, IFN‐γ, IL‐1β, TNF‐α, and Poly I:C. After 48 hr, mature aDC1s were harvested and suspended in two different solutions: normal saline and Ringer’s lactate. The maintenance of cells in suspension was evaluated after 4, 6, and 8 hr of storage. Cell viability, immunophenotyping, and apoptosis analyses were performed by flow cytometry. Cellular morphology was observed by electron microscopy, and the production of IL‐12p70 by aDC1s was evaluated by ELISA. Compared with normal saline, Ringer’s lactate solution was more effective at maintaining DC viability for up to 8 hr of incubation at 4 or 22°C.

2023-03-01·Glia

Elevated granulocyte colony stimulating factor (CSF) causes cerebellar deficits and anxiety in a model of CSF‐1 receptor related leukodystrophy

Article

作者: Khodakhah, Kamran ; Tindi, Jaafar ; DeTure, Michael A. ; Ketchum, Harmony C. ; Chitu, Violeta ; Burghardt, Nesha S. ; Wszolek, Zbignew K. ; Biundo, Fabrizio ; Dickson, Dennis W. ; Shlager, Gabriel G. L. ; Stanley, E. Richard

AbstractColony stimulating factor (CSF) receptor‐1 (CSF‐1R)‐related leukoencephalopathy (CRL) is an adult‐onset, demyelinating and neurodegenerative disease caused by autosomal dominant mutations in CSF1R, modeled by the Csf1r+/− mouse. The expression of Csf2, encoding granulocyte‐macrophage CSF (GM‐CSF) and of Csf3, encoding granulocyte CSF (G‐CSF), are elevated in both mouse and human CRL brains. While monoallelic targeting of Csf2 has been shown to attenuate many behavioral and histological deficits of Csf1r+/− mice, including cognitive dysfunction and demyelination, the contribution of Csf3 has not been explored. In the present study, we investigate the behavioral, electrophysiological and histopathological phenotypes of Csf1r+/− mice following monoallelic targeting of Csf3. We show that Csf3 heterozygosity normalized the Csf3 levels in Csf1r+/− mouse brains and ameliorated anxiety‐like behavior, motor coordination and social interaction deficits, but not the cognitive impairment of Csf1r+/− mice. Csf3 heterozygosity failed to prevent callosal demyelination. However, consistent with its effects on behavior, Csf3 heterozygosity normalized microglial morphology in the cerebellum and in the ventral, but not in the dorsal hippocampus. Csf1r+/− mice exhibited altered firing activity in the deep cerebellar nuclei (DCN) associated with increased engulfment of glutamatergic synapses by DCN microglia and increased deposition of the complement factor C1q on glutamatergic synapses. These phenotypes were significantly ameliorated by monoallelic deletion of Csf3. Our current and earlier findings indicate that G‐CSF and GM‐CSF play largely non‐overlapping roles in CRL‐like disease development in Csf1r+/− mice.

项与 GM-CSF(Sun Yat-sen University) 相关的新闻（医药）

2023-12-20

·PRNewswire

Exploratory Results Suggest the Potential Role of LEUKINE® as a Host-Directed Immunomodulator

Results of a prospective, randomized, placebo-controlled study of inhaled Leukine® in non-hospitalized patients at risk for severe COVID-19 LEXINGTON, Mass., Dec. 20, 2023 /PRNewswire/ -- Partner Therapeutics, Inc. (PTx) announced today that Open Forum Infectious Diseases recently published the results from the SCOPE study (doi.org/10.1093/ofid/ofad500.351).1 These data were also presented at IDWeek 2023. The study was a prospective, multicenter study of 600 non-hospitalized COVID-19 patients randomized to receive either inhaled Leukine® (sargramostim; yeast-derived, glycosylated recombinant human granulocyte-macrophage colony-stimulating factor [rhu GM-CSF]) or placebo. SCOPE included patients diagnosed with symptomatic mild/moderate COVID-19 who were at high risk for progression to severe disease. Of the 600 patients, 93 were vaccinated. Inhaled sargramostim, administered daily for five days, was well tolerated, no cytokine changes were observed, and adverse events were generally similar across both arms. The primary study endpoint was to determine if inhaled sargramostim could prevent progression to more severe disease as determined by any emergency room visit, hospitalization, or death by day 28. No difference was found in the primary endpoint between treatment arms. However, the sargramostim arm had a greater reduction in overall symptom score (a secondary endpoint) than the placebo arm. Results of prior studies of sargramostim in patients hospitalized with COVID-192,3 showed inhaled sargramostim plus standard of care led to greater improvement in P(A–a)O2, a measure of oxygenation, compared to standard of care alone. Exploratory analyses of a biomarker cohort (n=101, containing both vaccinated and unvaccinated patients) revealed potential immunomodulatory effects of sargramostim. Humoral and cellular immune signatures adjust to a multiplying SARS-CoV-2 viral load during the progression from mild to severe COVID-19.4,5 SCOPE investigators observed that treatment with inhaled sargramostim enhanced SARS-CoV-2 viral load clearance, modulated the humoral kinetics and magnitude against SAS-CoV-2 antigens, and suggested enhanced IgG4 expression and FcGR2B binding.2 The effect of sargramostim on humoral immune response was more pronounced in patients who have received a COVID-19 vaccination. The translational data from this study show modulation of humoral immunity with sargramostim treatment. Ila Joshi, Ph.D., Director of Biology, Pre-Clinical and Translational Research and Development at PTx observed, "The exploratory results from the biomarker cohort provide evidence of the potential for sargramostim to act as a virus-agnostic, host-directed immunomodulator. The combined effect of sargramostim and a COVID-19 vaccination observed on the humoral response, humoral kinetics, and viral load highlight a synergistic immune response against virus-specific antigens." This effort was funded by the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) under project agreement MCDC2006-012. Included references to commercial products do not constitute an endorsement by the U.S. Defense Department or the JPEO-CBRND. Leukine® is not approved to treat COVID-19. ABOUT IDWEEK IDWeek is the joint annual meeting of the Infectious Diseases Society of America, Society for Healthcare Epidemiology of America, the HIV Medicine Association, the Pediatric Infectious Diseases Society, and the Society of Infectious Diseases Pharmacists. IDWeek 2023 was held October 11-15, 2023, in Boston. ABOUT Leukine® Leukine® (sargramostim) is a glycosylated recombinant human granulocyte-macrophage colony-stimulating factor (rhu GM-CSF) produced by recombinant DNA technology in yeast. Leukine® is indicated: To shorten time to neutrophil recovery and to reduce the incidence of severe and life-threatening infections and infections resulting in death following induction chemotherapy in adult patients 55 years and older with acute myeloid leukemia. For the mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis and autologous transplantation in adult patients. For the acceleration of myeloid reconstitution following autologous bone marrow or peripheral blood progenitor cell transplantation in adult and pediatric patients two years of age and older. For the acceleration of myeloid reconstitution following allogeneic bone marrow transplantation in adult and pediatric patients two years of age and older. For treatment of delayed neutrophil recovery or graft failure after autologous or allogeneic bone marrow transplantation in adult and pediatric patients two years of age and older. To increase survival in adult and pediatric patients from birth to 17 years of age acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome). Important Safety Information for Leukine® (sargramostim) Contraindications Do not administer Leukine® to patients with a history of serious allergic reaction, including anaphylaxis, to human granulocyte-macrophage colony-stimulating factor, sargramostim, yeast-derived products, or any other component of Leukine®. Warnings and Precautions Serious hypersensitivity reactions, including anaphylactic reactions, have been reported with Leukine®. If a serious allergic or anaphylactic reaction occurs, immediately discontinue Leukine® therapy, and institute medical management. Discontinue Leukine® permanently for patients with serious allergic reactions. Leukine® can cause infusion-related reactions that may be characterized by respiratory distress, hypoxia, flushing, hypotension, syncope, and/or tachycardia. Observe closely during infusion, particularly in patients with preexisting lung disease; dose adjustment or discontinuation may be needed. Leukine® should not be administered simultaneously with or within 24 hours preceding cytotoxic chemotherapy or radiotherapy or within 24 hours following chemotherapy. Edema, capillary leak syndrome, and pleural or pericardial effusions have been reported in patients after Leukine® administration. Leukine® should be used with caution in patients with preexisting fluid retention, pulmonary infiltrates, or congestive heart failure. Such patients should be monitored. Supraventricular arrhythmia has been reported in uncontrolled studies during Leukine® administration, particularly in patients with a history of cardiac arrhythmia. Use Leukine® with caution in patients with preexisting cardiac disease. If absolute neutrophil count > 20,000 cells/mm3 or if white blood cell counts > 50,000/mm3, Leukine® administration should be interrupted, or the dose reduced by half. Monitor complete blood counts with differential twice per week. Discontinue Leukine® therapy if tumor progression, particularly in myeloid malignancies, is detected during Leukine® treatment. Treatment with Leukine® may induce neutralizing anti-drug antibodies. Use Leukine® for the shortest duration needed. Avoid administration of solutions containing benzyl alcohol (including Leukine® for injection reconstituted with Bacteriostatic Water for Injection, USP [0.9 % benzyl alcohol]) to neonates and low birth weight infants. Drug Interactions Avoid the concomitant use of Leukine® and products that induce myeloproliferation. Monitor for clinical and laboratory signs of excess myeloproliferative effects. Adverse Reactions Adverse events occurring in >10% of patients receiving Leukine® in controlled clinical trials and reported at a higher frequency than in placebo patients are: In recipients of autologous bone marrow transplantation–asthenia, malaise, diarrhea, rash, peripheral edema, urinary tract disorder. In recipients of allogeneic blood and marrow transplant–abdominal pain, chills, chest pain, diarrhea, nausea, vomiting, hematemesis, dysphagia, gastrointestinal hemorrhage, pruritus, bone pain, arthralgia, eye hemorrhage, hypertension, tachycardia, bilirubinemia, hyperglycemia, increased creatinine, hypomagnesemia, edema, pharyngitis, epistaxis, dyspnea, insomnia, anxiety, high glucose, low albumin. In patients with acute myeloid leukemia–fever, weight loss, nausea, vomiting, anorexia, skin reactions, metabolic laboratory abnormalities, edema. ABOUT PARTNER THERAPEUTICS Partner Therapeutics, Inc., an integrated biotechnology company, focuses on development and commercialization of late-stage therapeutics to improve health outcomes in treatment of cancer and other serious diseases. The company believes in delivering products and supporting medical teams with the purpose of achieving superior outcomes for patients and their families. Visit . ABOUT THE JPEO-CBRND The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) mission is to provide an integrated layered chemical, biological, radiological, and nuclear defense capabilities to the Joint Force across combined Joint All-Domain Operations. JPEO-CBRND's goal is to enable the Joint Force to fight and win unencumbered by a CBRN environment. To learn more about JPEO-CBRND, visit: , or follow JPEO-CBRND on social media @JPEOCBRND. References: 1 Joshi I, Garner F, Roychowdhury DF, et al. Inhaled Sargramostim (rhu GM-CSF) Leads to Enhanced SARS-CoV-2 Virus-Specific Immune Response and Viral Clearance: Results of the Biomarker Cohort of a Randomized, Double-Blind, Placebo-Controlled Phase 2b Trial in Non-Hospitalized Patients with COVID-19. Open Forum Infectious Diseases. 2023;10(Supplement 2). doi:10.1093/ofid/ofad500.351 2 Paine R, Chasse R, Halstead ES, et al. Inhaled Sargramostim (Recombinant Human Granulocyte-Macrophage Colony-Stimulating Factor) for COVID-19-Associated Acute Hypoxemia: Results of the Phase 2, Randomized, Open-Label Trial (iLeukPulm) [published online ahead of print, 2022 Dec 2]. Mil Med. 2022;188(7-8):e2629-e2638. doi:10.1093/milmed/usac362 3 Bosteels C, Van Damme KFA, De Leeuw E, et al. Loss of GM–CSF–Dependent Instruction of Alveolar Macrophages in COVID–19 Provides a Rationale for Inhaled GM–CSF Treatment. Cell Rep Med. 2022:100833. doi: 10.1016/j.xcrm.2022.100833 4 Galipeau Y, Greig M, Liu G, Driedger M, Langlois MA. Humoral Responses and Serological Assays in SARS-CoV-2 Infections. Front Immunol. 2020;11:610688. Published 2020 Dec 18. doi:10.3389/fimmu.2020.610688 5 Zhou X, Ye Q. Cellular Immune Response to COVID-19 and Potential Immune Modulators. Front Immunol. 2021;12:646333. Published 2021 Apr 30. doi:10.3389/fimmu.2021.646333 SOURCE Partner Therapeutics, Inc.

临床结果临床2期免疫疗法

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适应症	最高研发状态	国家/地区	公司	日期
鼻咽癌	临床2期	中国	中山大学	2023-09-15
口腔炎	临床2期	中国	中山大学	2023-09-15

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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


SITC2015	临床2期	黑色素瘤辅助	62	GM-CSF (3 μg/kg)	鏇淵鑰窪構淵構窪築繭(艱淵積窪餘願築觸襯鹹) = at a median follow-up of 79 months, this translated into a significantly longer recurrence-free survival (RFS) in the CpG-treated group (p=0.010) 衊網衊淵觸簾鑰顧遞鹹 (遞積製齋餘鹽衊鬱願襯 )	积极	2015-11-04
				CpG-B (PF-3512676/CpG7909, 8 mg)