GM-CSF

Phase 3Biologic

YY-mAbs Therapeutics

GM-CSF is one of 415 biologic programs targeting Nasopharyngeal Carcinoma. It is currently in Phase 3.

Indications

120

Total Trials

Active Trials

414

Competitors

Pipeline

Status by Indication[3][1]

Indication

Nasopharyngeal CarcinomaRecruiting

Autoimmune Pulmonary Alveolar ProteinosisUnknown status

NeuroblastomaCompleted

ParalysisActive, not recruiting

Malignant GliomaNot yet recruiting

Prostate CancerCompleted

Multiple MyelomaCompleted

Systemic SclerosisRecruiting

Metastatic Uveal MelanomaRecruiting

AINActive, not recruiting

Nasopharyngeal CarcinomaPhase 2

Recruiting

Autoimmune Pulmonary Alveolar ProteinosisPhase 2

Unknown status

NeuroblastomaPhase 2

Completed

ParalysisPhase 3

Active, not recruiting

Malignant GliomaPhase 2

Not yet recruiting

Prostate CancerPhase 3

Completed

Multiple MyelomaPhase 2

Completed

Systemic SclerosisPhase 2

Recruiting

Metastatic Uveal MelanomaPreclinical

Recruiting

AINPhase 3

Active, not recruiting

Showing 10 of 19 indications

Competition

Competitive Landscape

314 competitors in Prostate Cancer

#DrugCompanyPhaseTrials

Rubraca

Bristol-Myers Squibb

Phase 3

9 2

Paraplatin

AAvyxa

Phase 3

25 3

Alinamin

Roche

Phase 3

6 4

Verzenio

Eli Lilly

Phase 3

4 5

Orgovyx

Sumitomo Pharma America, Inc.

Phase 3

12 6

Truqap

AstraZeneca

Phase 3

2 7

GM-CSF

YY-mAbs Therapeutics

Phase 3

8 8

Provenge

PProstate Oncology Specialists, Inc.

Phase 3

21 9

Trexall

Jazz Pharmaceuticals

Preclinical

—10

Jatenzo

GGrupo Espanol de Tumores Neuroendocrinos

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 3Active, not recruiting

AIN

NCT04229979

Phase 1Active, not recruiting

Neoadjuvant Therapy

NCT05307835

Q2 2027

Phase 1Active, not recruiting

Neuroblastoma (NB)

NCT03189706

Phase 2Recruiting

Neuroblastoma

NCT04936529

Phase 2Not yet recruiting

Autoimmune Pulmonary Alveolar Proteinosis

NCT06989333

Q3 2027

Phase 2Active, not recruiting

Recurrent Osteosarcoma

NCT02502786

Clinical

Trials by Indication[1]

Melanoma10 trials

Vaccine Therapy in Treating Patients With Stage IIIB, Stage IIIC, or Stage IV Melanoma

Completed·UUniversity of Virginia·Phase 1/2·NCT00089219·39 enrolled

Neoadjuvant Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Cutaneous Stage L-lll Melanoma

Completed·MMayo Clinic·Phase 4·NCT02451488·8 enrolled

Vaccine Therapy in Treating Patients With Recurrent Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery

Completed·AAhmad Tarhini·Phase 1·NCT00471471·22 enrolled

Show 7 more trials

Efficacy and Safety Study of Talimogene Laherparepvec Compared to Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) in Melanoma

Completed·BBioVex Limited·Phase 3·NCT00769704·437 enrolled

Phase II Trial of (IL-2) With Priming and (GM-CSF) in Patients With Advanced Melanoma

Completed·MMt. Sinai Medical Center, Miami·Phase 2·NCT00616564·36 enrolled

Safety of UV1 Vaccination in Combination With Ipilimumab in Patients With Unresectable or Metastatic Malignant Melanoma

Completed·UUltimovacs ASA·Phase 1/2·NCT02275416·12 enrolled

REO13 Melanoma With of Without GM-CSF

Withdrawn·UUniversity of Leeds·Phase 1/2·NCT03282188

Vaccine Therapy and GM-CSF With or Without Low-Dose Aldesleukin in Treating Patients With Stage II, Stage III, or Stage IV Melanoma

Completed·MMayo Clinic·Phase 1·NCT00470015·20 enrolled

A Phase I/II Open-Label Study of Ipilimumab and GM-CSF Administered to Unresectable Stage IIIC and Stage IV Melanoma Patients

Completed·UUniversity of Louisville·Phase 1/2·NCT02009397·27 enrolled

Adoptive Transfer of MART1/Melan-A CTL for Malignant Melanoma

Completed·—·Phase 1·NCT00512889·9 enrolled

Neuroblastoma9 trials

Clinical Analysis of Naxitamab (hu3F8) in the Treatment of Pediatric High Risk or Refractory/ Relapsed Neuroblastoma

Recruiting·SSun Yat-Sen University Cancer Center·Phase 2·NCT06013618·120 enrolled

Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GMCSF) and Isotretinoin for Consolidation of Patients With High-Risk Neuroblastoma in First Remission.

Withdrawn·YY-mAbs Therapeutics·Phase 2·NCT04909515

A Study of Abemaciclib (LY2835219) in Combination With Other Anti-Cancer Treatments in Children and Young Adult Participants With Solid Tumors, Including Neuroblastoma

Completed· Eli Lilly logo

Eli Lilly·Phase 1/2·NCT04238819·47 enrolled

Show 6 more trials

Anti-GD2 3F8 Monoclonal Antibody and GM-CSF for High-Risk Neuroblastoma

Completed·MMemorial Sloan Kettering Cancer Center·N/A·NCT02100930·69 enrolled

Activated T Cells Armed With GD2 Bispecific Antibody in Children and Young Adults With Neuroblastoma and Osteosarcoma

Unknown status·UUniversity of Virginia·Phase 1/2·NCT02173093·40 enrolled

Hu3F8/GM-CSF Immunotherapy Plus Isotretinoin for Consolidation of First Remission of Patients With High-Risk Neuroblastoma: A Phase II Study

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT03033303·59 enrolled

Phase II Trial of a Bivalent Vaccine With the Immunological Adjuvant OPT-821 (QS-21), in Combination With Oral β-glucan and Randomization of GM-CSF, for High-risk Neuroblastoma

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT04936529·286 enrolled

Neuroblastoma Protocol 2012: Therapy for Children With Advanced Stage High-Risk Neuroblastoma

Completed·SSt. Jude Children's Research Hospital·Phase 2·NCT01857934·153 enrolled

Phase II Study of Ex-Vivo Expanded Allogeneic Universal Donor TGFβi NK Cell Infusions in Combination With Temozolomide, Irinotecan, Dinutuximab, and Sargramostim in Patients With Relapsed or Refractory Neuroblastoma The STING (Sequential Temozolomide, Irinotecan, NK Cells and GD2 mAb) Trial

Recruiting·NNew Approaches to Neuroblastoma Therapy Consortium·Phase 2·NCT06450041·62 enrolled

Prostate Cancer8 trials

pTVG-HP and Nivolumab in Patients With Non-Metastatic PSA-Recurrent Prostate Cancer

Active, not recruiting·UUniversity of Wisconsin, Madison·Phase 2·NCT03600350·19 enrolled

Activity of TroVax® Alone vs. TroVax® Plus GM-CSF in Patients With Prostate Cancer

Completed·TThe Methodist Hospital Research Institute·Phase 2·NCT00448409·27 enrolled

GM-CSF for Maintenance of Prostate Cancer for Patients Responding to Taxotere

Completed·OOncology Specialists, S.C.·Phase 2·NCT00274287·15 enrolled

Show 5 more trials

Phase II GM-CSF Plus Mitoxantrone in Hormone Refractory Prostate Cancer

Terminated·SStanford University·Phase 2·NCT00477087·10 enrolled

Safety and Efficacy Study of GM-CSF, Thalidomide Plus Docetaxel in Prostate Cancer

Terminated·TThe Methodist Hospital Research Institute·Phase 2·NCT00450008·9 enrolled

Trial of GM-CSF Given in Combination With Ketoconazole and Mitoxantrone in Patients With Progressive Prostate Cancer

Terminated·TThe Methodist Hospital Research Institute·Phase 2·NCT00447473·31 enrolled

A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F +/- GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic Castrate-Resistant Prostate Cancer

Completed·BBavarian Nordic·Phase 3·NCT01322490·1,297 enrolled

Ipilimumab and GMCSF Immunotherapy for Prostate Cancer

Withdrawn·LLawrence Fong·Phase 2·NCT01530984

Breast Cancer5 trials

Neoadjuvant Biweekly Treatment Followed by Weekly Treatment of Breast Cancer

Completed·RRita Sanghvi, Mehta·Phase 2·NCT00256243·48 enrolled

Vaccine Therapy in Treating Patients With Breast Cancer

Completed·SSan Antonio Military Medical Center·Phase 2·NCT00524277·456 enrolled

Neoadjuvant Treatment of Breast Cancer

Completed·UUniversity of California, Irvine·Phase 2·NCT00254592·43 enrolled

Show 2 more trials

Phase II Trial of Combination Immunotherapy With NeuVax and Trastuzumab in High-risk HER2+ Breast Cancer Patients

Completed·CCancer Insight, LLC·Phase 2·NCT02297698·100 enrolled

Herceptin and GM-CSF for Metastatic Breast Cancer

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00429104·18 enrolled

Lymphoma4 trials

Rituximab + GM-CSF in Patients With Follicular B-Cell Lymphoma

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT01939730·42 enrolled

CHOP-Rituximab Augmented With GM-CSF in Patients With Previously Untreated Diffuse Large B Cell Non-Hodgkin's Lymphoma

Terminated·MMassachusetts General Hospital·Phase 2·NCT00455897·3 enrolled

Autologous and Allogenic Transplantation With Campath-1H for T-Cell Lymphoma

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT00505921·27 enrolled

Show 1 more trial

A Pilot Study of Immunotherapy Including Haploidentical NK Cell Infusion Following CD133+ Positively-Selected Autologous Hematopoietic Stem Cells in Children With High Risk Solid Tumors or Lymphomas

Completed·SSt. Jude Children's Research Hospital·Phase 1·NCT02130869·8 enrolled

67 more indications

Multiple Myeloma3 trials

WT1 Vaccine Treatment of Patients With Multiple Myeloma After Autologous Stem Cell Transplantation

Completed·SSellas Life Sciences Group·Phase 1/2·NCT01827137·20 enrolled

Dendritic Cell/Myeloma Fusion Vaccine for Multiple Myeloma (BMT CTN 1401)

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 2·NCT02728102·203 enrolled

A Phase 1 Study of Vaccination With Dendritic Cell (DC)/Multiple Myeloma (MM) Fusions in Combination With Elranatamab in Relapsed or Refractory Multiple Myeloma

Recruiting·DDavid Avigan·Phase 1·NCT06799026·25 enrolled

Paralysis3 trials

The Effects of Immunostimulation With GM-CSF or IFN-y on Immunoparalysis Following Human Endotoxemia

Completed·RRadboud University Medical Center·N/A·NCT01374711·18 enrolled

GM-CSF for Reversal of Immunoparalysis in Pediatric Sepsis-induced MODS

Terminated·NNationwide Children's Hospital·Phase 3·NCT05266001·141 enrolled

GM-CSF for Reversal of immunopAralysis in pediatriC sEpsis-induced MODS Study

Active, not recruiting·NNationwide Children's Hospital·Phase 4·NCT03769844·120 enrolled

Advanced Refractory Solid Tumors3 trials

Hypofractionated Radiotherapy Combined With PD-1 Inhibitor Sequential GM-CSF and IL-2 for the Treatment of Advanced Refractory Solid Tumors (PRaG2.0)

Unknown status·SSecond Affiliated Hospital of Soochow University·Phase 2·NCT04892498·66 enrolled

Thymalfasin-based PRaG Mode for Advanced Refractory Solid Tumors

Unknown status·SSecond Affiliated Hospital of Soochow University·Phase 2·NCT05790447·60 enrolled

Cetuximab β Combined With PRaG Regimen in the Treatment of EGFR-positive Advanced Refractory Solid Tumors

Not yet recruiting·SSecond Affiliated Hospital of Soochow University·Phase 2·NCT07327411·40 enrolled

Autoimmune Pulmonary Alveolar Proteinosis3 trials

Sequential Therapy With WLL/Inhaling GM-CSF for Autoimmune Pulmonary Alveolar Proteinosis

Unknown status·DDai Huaping·Phase 2·NCT03316651·60 enrolled

Local Spraying of GM-CSF Via Bronchoscopy in the Treatment of Autoimmune Pulmonary Alveolar Proteinosis

Not yet recruiting·JJiuwu Bai·Phase 2·NCT06989333·10 enrolled

Inhalation of Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) for Autoimmune Pulmonary Alveolar Proteinosis (PAP)

Unknown status·PPeking Union Medical College Hospital·Phase 2·NCT02243228·42 enrolled

Ovarian Cancer3 trials

Chemoimmunotherapy Study for Patients With Epithelial Ovarian Cancer

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00501644·59 enrolled

GM-CSF, Sargramostim in Women With Recurrent Ovarian Cancer

Completed·MMassachusetts General Hospital·Phase 2·NCT00157573·72 enrolled

Vaccination of Patients With Ovarian Cancer With Dendritic Cell/Tumor Fusions With GM-CSF and Imiquimod

Terminated·BBeth Israel Deaconess Medical Center·Phase 2·NCT00799110·15 enrolled

Follicular Lymphoma2 trials

Active Specific Immunotherapy for Follicular Lymphomas With Tumor-Derived Immunoglobulin Idiotype Antigen Vaccines

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00001512·42 enrolled

Sequential Intranodal Immunotherapy (SIIT) Combined With Anti-PD1 (Pembrolizumab) in Follicular Lymphoma

Completed·OOslo University Hospital·Phase 2·NCT02677155·10 enrolled

Dendritic Cell2 trials

A Comparison of Dendritic Cell Content and T-Cell Phenotype Between Granulocyte Colony-Stimulating Factor (G-CSF) or G-CSF + Granulocyte Macrophage (GM)-CSF

Terminated·EEmory University·Phase 2·NCT00208949·50 enrolled

Vaccine Biotherapy of Cancer: Autologous Tumor Cells and Dendritic Cells

Completed·HHoag Memorial Hospital Presbyterian·Phase 2·NCT00948480·56 enrolled

Vaccine2 trials

DC/MM Fusion Vaccine With BCMA CAR-T in R/R MM

Not yet recruiting·DDavid Avigan·Phase 1·NCT07377435·25 enrolled

A Phase I Study of a DNA Vaccine Encoding Androgen Receptor Ligand-Binding Domain (AR LBD) +/-GMCSF

Completed·UUniversity of Wisconsin, Madison·Phase 1·NCT02411786·40 enrolled

Metastatic Melanoma2 trials

UV1 Vaccine With Pembrolizumab for Patients With Unresectable or Metastatic Melanoma

Completed·UUltimovacs ASA·Phase 1·NCT03538314·30 enrolled

Vaccination With Tumor mRNA in Metastatic Melanoma - Fixed Combination Versus Individual Selection of Targeted Antigens

Completed·UUniversity Hospital Tuebingen·Phase 1/2·NCT00204516·31 enrolled

Acute Lymphoblastic Leukemia2 trials

Immunotherapy for Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Blast Phase Chronic Myelogenous Leukemia (BP CML), and Myelodysplastic Syndrome (MDS) Relapse After Allogeneic Transplantation

Completed·EEmory University·Phase 2·NCT00548847·15 enrolled

WT1 Vaccine Treatment of Patients in Remission From Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL)

Completed·SSellas Life Sciences Group·Phase 2·NCT01266083·22 enrolled

Immune Response2 trials

Safety of and Immune Response to a New HIV Vaccine: HIV CTL MEP

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00076037·96 enrolled

Safety and Immune Response to FMPV-1

Completed·HHubro Therapeutics AS·Phase 1·NCT05238558·16 enrolled

Non-Small Cell Lung Cancer2 trials

Combination Vaccine Immunotherapy (DRibbles) for Patients With Definitively-Treated Stage III Non-small Cell Lung Cancer

Completed·UUbiVac·Phase 2·NCT01909752·12 enrolled

Vinorelbine Metronomic Chemotherapy Combined With Hypofractionated Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2 for Treatment of Advanced Refractory Non-small Cell Lung Cancer and Breast Cancer(PRaG 6.0)

Unknown status·SSecond Affiliated Hospital of Soochow University·Phase 2·NCT05603013·45 enrolled

Stem Cell1 trial

G-CSF Versus G-CSF Plus GM-CSF for Stem Cell Mobilization in NHL Patients

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00499343·84 enrolled

Endometrial1 trial

The Effect of the GM-CSF Gel on the Endometrial Thickness in Infertile Women With Thin Endometrium

Unknown status·SSir Run Run Shaw Hospital·N/A·NCT04100655·96 enrolled

Immunomodulation1 trial

GM-CSF for Immunomodulation Following Trauma (GIFT) Study

Completed·MMark Hall·Phase 4·NCT01495637·108 enrolled

Transplantation1 trial

A Pilot Study of Tumor-Specific Peptide Vaccination and IL-2 With or Without Autologous T Cell Transplantation in Recurrent Pediatric Sarcomas

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00001564·30 enrolled

Trial1 trial

NB2013-HR German (GPOH) / Dutch (DCOG) Trial

Terminated·UUniversity of Cologne·Phase 2·NCT02641782·3 enrolled

Prostate1 trial

Study of Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) for Patients With Rising Prostate-Specific Antigen (PSA)

Completed·UUniversity of California, San Francisco·Phase 2·NCT00678054·30 enrolled

Natural Killer Cell1 trial

In Vitro Expanded Autologous Invariant Natural Killer Cells in Cancer

Completed·—·Phase 1·NCT00631072·9 enrolled

Advanced NSCLC1 trial

SBRT in Combination With Sintilimab and GM-CSF for the Treatment of Advanced NSCLC

Unknown status·FFudan University·Phase 2·NCT04106180·63 enrolled

Randomized1 trial

A Randomized Trial of GM-CSF in Patients With ALI/ARDS

Completed·UUniversity of Michigan·Phase 2·NCT00201409·132 enrolled

Pancreatic Adenocarcinoma1 trial

Administration as a Biological Adjuvant in Clinically-Staged, Resectable Pancreatic Adenocarcinoma

Completed·EEdward Nelson·Phase 1·NCT00600002·30 enrolled

Interleukin1 trial

Immune Mobilization of Autologous Peripheral Blood Stem Cells Using Interleukin-2 and GM-CSF

Completed·—·Phase 1·NCT00952237·13 enrolled

Remission1 trial

Trial of ID-Specific Donor Vaccinated Lymphocyte Infusion for Patients With Myeloma Relapsing or Failing to Achieve a Complete Remission After an Allogenic Transplant

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT01174082·2 enrolled

Tics1 trial

First-time-in-Human (FTIH) Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single (in Both Fed and Fasted States) or Repeat Doses of GSK3358699

Terminated· GSK logo

GSK·Phase 1·NCT03426995·48 enrolled

Advanced Cancers1 trial

Galinpepimut-S in Combination With Pembrolizumab in Patients With Selected Advanced Cancers

Completed·SSellas Life Sciences Group·Phase 1/2·NCT03761914·26 enrolled

First Line Therapy1 trial

Phase II Trial of FOLFOXIGIL Versus FOLFOXIRI as First-line Therapy in Patients With mCRC

Withdrawn·FFujian Cancer Hospital·Phase 2·NCT03222089

Nasopharyngeal Carcinoma1 trial

The Effect of GM-CSF to Preventing Oral Mucositis for Patients With Nasopharyngeal Carcinoma Receiving Radiotherapy

Recruiting·SSun Yat-sen University·Phase 2·NCT06472739·138 enrolled

Malignant Tumor1 trial

G-CSF Alone or Combination With GM-CSF on Prevention and Treatment of Infection in Children With Malignant Tumor

Unknown status·XXinhua Hospital, Shanghai Jiao Tong University School of Medicine·Phase 4·NCT02933333·405 enrolled

Mantle Cell Lymphoma1 trial

Chemotherapy Plus Vaccination to Treat Mantle Cell Lymphoma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00005780·26 enrolled

Combination Therapy1 trial

IBI188 Combination Therapy in Solid Tumors

Terminated· Innovent Biologics (Suzhou) Co. Ltd. logo

Innovent Biologics (Suzhou) Co. Ltd.·Phase 1·NCT04861948·9 enrolled

Advanced Solid Tumors1 trial

PRaG Regimens Rechallenge for Patients With Resistance to PD1/PD-L1 Inhibitors in Refractory Advanced Solid Tumors.

Unknown status·SSecond Affiliated Hospital of Soochow University·Phase 2·NCT05530200·56 enrolled

Glioblastoma Multiforme1 trial

ERC1671/GM-CSF/Cyclophosphamide for the Treatment of Glioblastoma Multiforme

Active, not recruiting·EEpitopoietic Research Corporation·Phase 2·NCT01903330·84 enrolled

Relapsed/Refractory1 trial

Anti-CD30 biAb-AATC in Patients With Relapsed/Refractory CD30 Positive Hematopoietic Malignancies

Not yet recruiting·MMedical College of Wisconsin·Phase 1·NCT05544968·42 enrolled

Radiotherapy1 trial

Radiotherapy in Combination With Sintilimab，GM-CSF and Fruquintinib in Patients With MSS mCRC

Unknown status·TThe First Affiliated Hospital of Xiamen University·Phase 2·NCT05292417·71 enrolled

Bone Marrow Transplantation1 trial

Active Immunization of Sibling Bone Marrow Transplant Donors Against Purified Myeloma Protein of the Recipient Undergoing Allogeneic Bone Marrow Transplantation

Completed·NNational Cancer Institute (NCI)·Phase 3·NCT00001561·30 enrolled

AIN1 trial

Galinpepimut-S Versus Investigator's Choice of Best Available Therapy for Maintenance in AML CR2/CRp2

Active, not recruiting·SSellas Life Sciences Group·Phase 3·NCT04229979·127 enrolled

Embryo1 trial

Effects of Embryogen in RIF Patients

Completed·VVietnam National University·Phase 4·NCT02250768·60 enrolled

Colorectal Cancer1 trial

Safety Study of DNA Vaccine Delivered by Intradermal Electroporation to Treat Colorectal Cancer

Completed·MMaria Liljefors·Phase 1/2·NCT01064375·16 enrolled

Advanced Malignancies1 trial

Study of REGN2810 (Anti-PD-1) in Patients With Advanced Malignancies

Completed· Regeneron logo

Regeneron·Phase 1·NCT02383212·398 enrolled

Head and Neck Tumors1 trial

Radiotherapy Combined With PD-1 Inhibitor and GM-CSF for Advanced Recurrent Metastatic Head and Neck Tumors

Unknown status·XXiangpan Li·Phase 2·NCT05760196·56 enrolled

Kidney Cancer1 trial

PEG-Interferon Alfa-2b, Sargramostim, and Thalidomide in Treating Patients With Metastatic Kidney Cancer

Terminated·MMedical University of South Carolina·Phase 2·NCT00090870·10 enrolled

Septic Shock1 trial

Reconstruction of Monocytic Immunocompetence by Granulocyte-macrophage-colony Stimulating Factor (GM-CSF) in Patients With Severe Sepsis and Septic Shock

Completed·—·Phase 2·NCT00252915·38 enrolled

Pulmonary Alveolar Proteinosis1 trial

GM-CSF in Patients With Pulmonary Alveolar Proteinosis

Terminated·TThe Cleveland Clinic·Phase 2·NCT00030056·48 enrolled

Vaccination1 trial

Peptide Vaccinations to Treat Patients With Low-Risk Myeloid Cancers

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 2·NCT00488592·10 enrolled

Chronic Lymphocytic Leukemia1 trial

Rituximab Plus Sargramostim (GM-CSF) In Patients With Chronic Lymphocytic Leukemia

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00940342·130 enrolled

Solid Cancer1 trial

A Phase 2 Trial for Patients With Metastatic Solid Cancer

Active, not recruiting·RRampart Health, L.L.C.·Phase 2·NCT04713371·32 enrolled

Immunotherapy1 trial

Combination Immunotherapy With Herceptin and the HER2 Vaccine NeuVax

Completed·GGeorge E. Peoples·Phase 2·NCT01570036·275 enrolled

Clinical Trial1 trial

Metastatic Solid Cancer Clinical Trial

Active, not recruiting·IImmunSYS, LLC·Phase 2·NCT04739618·32 enrolled

Colon and Rectal Cancer1 trial

Cellular Immune Augmentation in Colon and Rectal Cancer

Completed·UUniversity of California, Irvine·Phase 2·NCT00257322·20 enrolled

HIV-1 infection1 trial

Novel Interventions in HIV-1 Infection

Terminated·IImperial College London·Phase 1·NCT01130376·12 enrolled

Malignant Glioma1 trial

ERC1671 to Treat Malignant Gliomas When Given in Combination With GM-CSF, Cyclophosphamide, Bevacizumab and Pembrolizumab

Not yet recruiting·EEpitopoietic Research Corporation·Phase 2·NCT05366062·28 enrolled

Myelodysplastic Syndrome1 trial

Study of Azacytidine Followed by GM-CSF in Patients With Myelodysplastic Syndrome (MDS)

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT01542684·8 enrolled

Not yet recruiting·DDavid Avigan·Phase 1·NCT07374029·30 enrolled

Allogeneic Stem Cell Transplantation1 trial

Immunotherapy With NK Cell, Rituximab and Rhu-GMCSF in Non-Myeloablative Allogeneic Stem Cell Transplantation

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT00383994·6 enrolled

Renal Cell Carcinoma1 trial

IMA901 in Patients Receiving Sunitinib for Advanced/Metastatic Renal Cell Carcinoma

Completed·IImmatics Biotechnologies GmbH·Phase 3·NCT01265901·339 enrolled

Adjuvant1 trial

Proteinase 3 PR1 Peptide Mixed With Montanide ISA-51 VG Adjuvant and Administered With GM-CSF and PEG-INTRON(R)

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT00415857·5 enrolled

Acute Myeloid Leukemia1 trial

Effect of Priming During Induction and Consolidations in Younger Acute Myeloid Leukemia (AML)

Completed·AAcute Leukemia French Association·Phase 3·NCT00880243·473 enrolled

Glioma1 trial

Immunotherapy Targeted Against Cytomegalovirus in Patients With Newly-Diagnosed WHO Grade IV Unmethylated Glioma

Terminated·MMustafa Khasraw, MBChB, MD, FRCP, FRACP·Phase 2·NCT03927222·6 enrolled

Chronic Myelogenous Leukemia1 trial

Autologous Stem Cell Transplants for Chronic Myelogenous Leukemia

Withdrawn·MM.D. Anderson Cancer Center·Phase 2·NCT00446173

Systemic Sclerosis1 trial

Autologous Stem Cell Transplantation With CD34-Selected Peripheral Blood Stem Cells (PBSC) in Patients With Treatment Resistant Systemic Sclerosis (SSc)

Recruiting·PPaul Szabolcs·Phase 2·NCT03630211·8 enrolled

Peripheral Artery Disease (PAD)1 trial

Granulocyte-Macrophage Stimulating Factor (GM-CSF) in Peripheral Arterial Disease: The GPAD-3 Study

Completed·EEmory University·Phase 2·NCT03304821·114 enrolled

Recurrent Osteosarcoma1 trial

A Phase II Study of Humanized Monoclonal Antibody 3F8 (Hu3F8) With Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in the Treatment of Recurrent Osteosarcoma

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT02502786·46 enrolled

Metastatic Uveal Melanoma1 trial

A Phase I/II Study of Tebentafusp-tebn in Combination With Liver-Directed Therapies for the Treatment of Metastatic Uveal Melanoma

Recruiting·TThomas Jefferson University·Preclinical·NCT06626516·109 enrolled

Neuroblastoma (NB)1 trial

Phase II Study of Hu3F8, Irinotecan/Temozolomide and Sargramostim (HITS) Chemoimmunotherapy for High-Risk Neuroblastoma

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT03189706·48 enrolled

Sources

References

[1]
ClinicalTrials.gov — 120 trial records for GM-CSF. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — GM-CSF compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for GM-CSF. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Y-mAbs Therapeutics company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Biologic[2]
Highest Phase: Phase 3[1]
Company: YY-mAbs Therapeutics

GM-CSF

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Q3 2027

Trials by Indication[1]

Melanoma10 trials

Neuroblastoma9 trials

Prostate Cancer8 trials

Breast Cancer5 trials

Lymphoma4 trials

Multiple Myeloma3 trials

Paralysis3 trials

Advanced Refractory Solid Tumors3 trials

Autoimmune Pulmonary Alveolar Proteinosis3 trials

Ovarian Cancer3 trials

Follicular Lymphoma2 trials

Dendritic Cell2 trials

Vaccine2 trials

Metastatic Melanoma2 trials

Acute Lymphoblastic Leukemia2 trials

Immune Response2 trials

Non-Small Cell Lung Cancer2 trials

Stem Cell1 trial

Endometrial1 trial

Immunomodulation1 trial

Transplantation1 trial

Trial1 trial

Prostate1 trial

Natural Killer Cell1 trial

Advanced NSCLC1 trial

Randomized1 trial

Pancreatic Adenocarcinoma1 trial

Interleukin1 trial

Remission1 trial

Tics1 trial

Advanced Cancers1 trial

First Line Therapy1 trial

Nasopharyngeal Carcinoma1 trial

Malignant Tumor1 trial

Mantle Cell Lymphoma1 trial

Combination Therapy1 trial

Advanced Solid Tumors1 trial

Glioblastoma Multiforme1 trial

Relapsed/Refractory1 trial

Radiotherapy1 trial

Bone Marrow Transplantation1 trial

AIN1 trial

Embryo1 trial

Colorectal Cancer1 trial

Advanced Malignancies1 trial

Head and Neck Tumors1 trial

Kidney Cancer1 trial

Septic Shock1 trial

Pulmonary Alveolar Proteinosis1 trial

Vaccination1 trial

Chronic Lymphocytic Leukemia1 trial

Solid Cancer1 trial

Immunotherapy1 trial

Clinical Trial1 trial

Colon and Rectal Cancer1 trial

HIV-1 infection1 trial

Malignant Glioma1 trial

Myelodysplastic Syndrome1 trial

Uveal Melanoma1 trial

Neoadjuvant Therapy1 trial

T Cell Therapy1 trial

Allogeneic Stem Cell Transplantation1 trial

Renal Cell Carcinoma1 trial

Adjuvant1 trial

Acute Myeloid Leukemia1 trial

Glioma1 trial

Chronic Myelogenous Leukemia1 trial

Systemic Sclerosis1 trial

Peripheral Artery Disease (PAD)1 trial

Recurrent Osteosarcoma1 trial

Metastatic Uveal Melanoma1 trial

Neuroblastoma (NB)1 trial