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GM-CSF

Phase 3

Lymphoma | Small molecule | Oncology |Bayer AG|Trials Updated: Jul 31, 2019

GM-CSF development status

Highest phase Phase 3 (NCT00237575)
Phase scored for BAYRYPhase 1
Registered trials 64 across 35 sponsors since Aug 2001

GM-CSF target and mechanism

ModalitySmall molecule

Also known as Sargramostim, Leukine

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment6

FDA Designations

No designations recorded

GM-CSF clinical trials

GM-CSF · 1 trial · 5 indications

Phase 1 1
NCT00383994Immunotherapy With NK Cell, Rituximab and Rhu-GMCSF in Non-Myeloablative Allogeneic Stem Cell TransplantationLymphoma
COMPLETED6 Analytics
PHASE1COMPLETED
Immunotherapy With NK Cell, Rituximab and Rhu-GMCSF in Non-Myeloablative Allogeneic Stem Cell Transplantation
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Study Endpoints

Primary Endpoints

Dose-limiting toxicities (DLTs) for NK cells infusions after non-myeloablative transplantation for lymphoid malignancies
Evaluated for toxicity within 6 weeks of treatment

Maximum tolerated dose (MTD) is the highest dose with 10 patients treated and 5 or fewer patients with DLT.

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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Immunotherapy with NK Cell, Rituximab + GM-CSFEXPERIMENTALImmunotherapy in Non-myeloablative Allogeneic Stem Cell Transplantation GM-CSF = Granulocyte-Macrophage Colony-Stimulating Factor

Interventions

NameTypeDescription
GM-CSFDRUG250 micrograms subcutaneously 3 times a week for 4 weeks starting a day before the administration of Rituximab.
RituximabDRUG375 mg/m\^2 by vein followed by 1000 mg/m\^2 weekly for 3 weeks for a total of 4 doses.
NK Cell InfusionBIOLOGICALNK cells will be infused one week after the fourth dose of Rituximab and GM-CSF.
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Eligibility Criteria

SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Patients with previous diagnosis of CD20+ B-cell CLL and non-Hodgkin's lymphoma who have failed standard conventional chemotherapy, and who had persistent disease at 3 months, or progressive disease after non-myeloablative allogeneic transplantation. 2. Donor willingness to d...

Countries:United States
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Competitive Landscape -Lymphoma 504 trials

Top 20 of 68 competitors

CompanyTickerTrialsLead PhaseDrugs
Regeneron Pharmaceuticals, Inc.REGN8PHASE3Odronextamab, REGN9220, REGN5837
Merck & Co., Inc.MRK22PHASE3Nemtabrutinib, Zilovertamab vedotin, Pembrolizumab Berahyaluronidase alfa, Pembrolizumab, MK-1045
Eli Lilly and CompanyLLY12PHASE3Pirtobrutinib, LY4152199, LY4584180
Genmab A/S Sponsored ADRGMAB17PHASE3Epcoritamab
AstraZeneca PLCAZN21PHASE3Acalabrutinib, Surovatamig, AZD0486, AZD4512, AZD5492
Novartis AG Sponsored ADRNVS9PHASE3Tisagenlecleucel, Rapcabtagene autoleucel, PIT565, Tulmimetostat
Incyte CorporationINCY15PHASE3Tafasitamab, parsaclisib, Ruxolitinib
Gilead Sciences, Inc.GILD7PHASE3Axicabtagene Ciloleucel, KITE-753, KTE-X19, KITE-197, INT2104
AbbVie, Inc.ABBV14PHASE3Venetoclax, Epcoritamab, ABBV-319, ABBV-453, ABBV-525
Johnson & JohnsonJNJ15PHASE3Ibrutinib, Bortezomib, JNJ-90009530, JNJ-80948543, JNJ-75348780
BeOne Medicines Ltd. Sponsored ADRONC23PHASE3Tacabrutideg, Zanubrutinib, Lenalidomide, Tislelizumab, Sonrotoclax
Bristol-Myers Squibb CompanyBMY19PHASE3Golcadomide, Lenalidomide, Lisocabtagene maraleucel, Nivolumab, CC-122
Pfizer Inc.PFE4PHASE3Brentuximab vedotin, Rituximab, Axitinib, Bosutinib, Crizotinib
Nurix Therapeutics, Inc.NRIX6PHASE3NX-5948, NX-1607, NX-2127
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
ADC Therapeutics LtdADCT3PHASE3Loncastuximab tesirine
Cellectar Biosciences, Inc.CLRB3PHASE3Iopofosine I-131
Nuvalent, Inc. Class ANUVL1PHASE3Neladalkib
HUTCHMED (China) Limited Sponsored ADRHCM1PHASE3HMPL-760
Corvus Pharmaceuticals, Inc.CRVS2PHASE3Soquelitinib
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