10 completed, 7 unknown, 1 active not recruiting, 1 available. 14 Phase 2, 5 Phase 1, 2 Phase 3, 1 Not applicable.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 14 | Completed 7, Unknown 5, Terminated 1, Withdrawn 1 |
| Phase 1 | 5 | Completed 3, Unknown 2 |
| Phase 3 | 2 | Active not recruiting 1, Recruiting 1 |
| Not applicable | 1 | Unknown 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Inhaled Molgramostim in Pediatric Participants With Autoimmune Pulmonary Alveolar Proteinosis (aPAP). Molgramostim - Autoimmune Pulmonary Alveolar Proteinosis | Phase 3 | Recruiting | Savara Inc. | 5 | 2025-10-22 | 2026-02-19 |
| PD-1 Inhibitor Intraperitoneal Perfusion Combined With PRaG Therapy for Malignant Ascites Serplulimab, Molgramostim, Hypofractionated radiotherapy/Sterotactic body radiotherapy - Malignant Ascites | Phase 1 / Phase 2 | Unknown | Second Affiliated Hospital of Soochow University | 40 | 2022-09-01 | 2022-08-15 |
| Clinical Trial of Inhaled Molgramostim Nebulizer Solution in Autoimmune Pulmonary Alveolar Proteinosis (aPAP) Molgramostim, Placebo, Molgramostim Open-label - Autoimmune Pulmonary Alveolar Proteinosis | Phase 3 | Active not recruiting | Savara Inc. | 164 | 2021-05-19 | 2026-11-03 |
| Effect of rhGM-CSF on the Healing of Venous Leg Ulcers rhGM-CSF + hydrogel, Placebo hydrogel, Standard care - Venous Leg Ulcer | Phase 2 | Unknown | Reponex Pharmaceuticals A/S | 6 | 2021-03-11 | 2022-11-17 |
| A Personalized NeoAntigen Cancer Vaccine Combined With Anti-PD-1 in Melanoma Peptide, Anti-PD-1, rhGM-CSF - Melanoma (Skin) | Phase 1 | Unknown | Xiangya Hospital of Central South University | 30 | 2020-04-21 | 2020-04-28 |
| Trial of Inhaled Molgramostim in Cystic Fibrosis Subjects With Nontuberculous Mycobacterial Infection Molgramostim nebulizer solution, PARI eFlow nebulizer system - Mycobacterium Infections, Nontuberculous, Cystic Fibrosis (CF) | Phase 2 | Terminated | Savara Inc. | 14 | 2019-06-20 | 2023-01-10 |
| Intraperitoneal Administration of Fosfomycin, Metronidazole and Molgramostim Versus Intravenous Antibiotics for Perforated Appendicitis Combination of fosfomycin, metronidazole and rhGM-CSF (administered together intraperitoneally) and three days of antibiotics p.o., Standard antibiotics intravenously - Appendicitis Perforated | Phase 2 | Completed | Herlev Hospital | 13 | 2018-02-14 | 2018-10-16 |
| Chemotherapy Combination With Local Radiotherapy and rhGM-CSF for Oligometastatic Stage IV NSCLC Patients rhGM-CSF, Pemetrexed, Local Radiotherapy - Carcinoma, Non-Small-Cell Lung | Not applicable | Unknown | Shandong Cancer Hospital and Institute | 45 | 2018-01-15 | 2018-04-05 |
| Abscopal Effect of Radiation in Combination With rhGM-CSF for Metastatic Non-small Cell Lung Cancer Radiotherapy, rhGM-CSF - Lung Cancer Metastatic | Phase 2 | Completed | Peking University Cancer Hospital & Institute | 40 | 2017-08-14 | 2023-06-13 |
| Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF) Inhalation to Improve Host Defense and Pulmonary Barrier Restoration inhaled molgramostim (rhGM-CSF), inhaled placebo - ARDS | Phase 2 | Completed | University of Giessen | 45 | 2016-06-01 | 2023-08-31 |
| A Study of SBRT in Combination With rhGM-CSF for Stage IV NSCLC Patients Who Failed in Second-line Chemotherapy Stereotactic body radiotherapy, rhGM-CSF - Carcinoma, Non-Small-Cell Lung | Phase 2 | Withdrawn | Wuhan University | 2016-05-01 | 2018-10-15 | |
| Efficacy and Safety of Inhaled Molgramostim (rhGM-CSF) in Autoimmune Pulmonary Alveolar Proteinosis Molgramostim, Placebo, PARI eFlow nebulizer system - Autoimmune Pulmonary Alveolar Proteinosis | Phase 2 | Completed | Savara Inc. | 139 | 2016-03-21 | 2023-04-12 |
| A Phase I Study of a DNA Vaccine Encoding Androgen Receptor Ligand-Binding Domain (AR LBD) +/-GMCSF pTVG-AR, gm-csf - Prostate Cancer | Phase 1 | Completed | University of Wisconsin, Madison | 40 | 2015-08-24 | 2021-02-04 |
| RhGM-CSF as Adjuvant Immunotherapy in Treating Stage III Colon Cancer rhGM-CSF, placebo - Colon Cancer | Phase 2 | Unknown | The Affiliated Hospital of the Chinese Academy of Military Medical Sciences | 60 | 2015-06-01 | 2016-01-20 |
| Inhaled Molgramostim (rhGM-CSF) in Healthy Adult Subjects Molgramostim, Placebo - Pulmonary Alveolar Proteinosis, Bronchiectasis | Phase 1 | Completed | Savara Inc. | 42 | 2015-05-01 | 2017-02-23 |
| Provenge With or Without pTVG-HP DNA Booster Vaccine in Prostate Cancer sipuleucel-T, DNA Vaccine - Prostate Cancer | Phase 2 | Completed | University of Wisconsin, Madison | 18 | 2013-05-20 | 2021-06-18 |
| Recombinant Human Granulocyte Macrophage Colony Stimulating Factor(rhGM-CSF) Treating Oral Mucositis rhGM-CSF, Compound Vitamin B12 - Nasopharyngeal Cancers | Phase 2 | Unknown | Wei LUO | 160 | 2013-03-01 | 2013-03-29 |
| Study of Subcutaneous Injection of Low-dose rhGM-CSF +/- WLL in PAP. rhGM-CSF, Whole Lung Lavage(WLL) - Pulmonary Alveolar Proteinosis | Phase 2 | Unknown | Shanghai Pulmonary Hospital, Shanghai, China | 40 | 2012-01-01 | 2013-11-18 |
| Phase II PAP Plus GM-CSF Versus GM-CSF Alone for Non-metastatic Prostate Cancer pTVG-HP, rhGM-CSF - Prostate Cancer | Phase 2 | Completed | University of Wisconsin, Madison | 99 | 2011-05-23 | 2021-01-20 |
| Two-Arm Study of a DNA Vaccine Encoding Prostatic Acid Phosphatase (PAP) in Patients With Non-Metastatic Castrate-Resistant Prostate Cancer pTVG-HP with rhGM-CSF - Prostate Cancer | Phase 2 | Completed | University of Wisconsin, Madison | 17 | 2009-03-16 | 2019-11-21 |
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Prostatic Neoplasms (5) · Pulmonary Alveolar Proteinosis (4) · Pulmonary Alveolar Proteinosis, Acquired (4) · Carcinoma, Non-Small-Cell Lung (2) · Cystic Fibrosis (2) · Acute Lung Injury (1) · Appendicitis (1) · Bronchiectasis (1) · Colonic Neoplasms (1) · Melanoma (1) · Mycobacterium Infections, Nontuberculous (1) · Nasopharyngeal Neoplasms (1) · Neoplasm Metastasis (1) · Neoplasms (1) · Pneumonia (1)
Savara Inc. (6) · University of Wisconsin, Madison (5) · Herlev Hospital (1) · Peking University Cancer Hospital & Institute (1) · Reponex Pharmaceuticals A/S (1) · Second Affiliated Hospital of Soochow University (1) · Shandong Cancer Hospital and Institute (1) · Shanghai Pulmonary Hospital, Shanghai, China (1) · The Affiliated Hospital of the Chinese Academy of Military Medical Sciences (1) · University of Giessen (1) · Wei LUO (1) · Wuhan University (1) · Xiangya Hospital of Central South University (1)
United States (9) · China (7) · Germany (4) · Denmark (3) · United Kingdom (3) · Australia (2) · France (2) · Greece (2) · Italy (2) · Japan (2) · Netherlands (2) · Portugal (2) · South Korea (2) · Spain (2) · Turkey (Türkiye) (2)
Douglas McNeel, M.D., PhD (2) · Douglas McNeel, MD (2) · Anhui Shi, MD. (1) · Bruce Trapnell, MD (1) · Cliff Morgan, MD (1) · Conghua Xie, MD, PhD (1) · Douglas G. McNeel, M.D., Ph.D. (1) · Ewa A Burian, MD (1) · Huiping Li, Dr (1) · Jerry Nick, MD (1) · Johnston Steward, MD (1) · Matthias Griese, MD, (1) · Susanne Herold, Prof.Dr.med.,PhD (1)
PMID 39208856, PMID 26095785, PMID 27789196, PMID 28678778, PMID 28678784, PMID 28716080, PMID 29534736, PMID 31644357, PMID 31898493, PMID 32432123, PMID 32513836, PMID 40834301, PMID 40973220
2015 (1)