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Lenzilumab

BIOLOGICAL5 trials

Sponsors

Humanigen, Inc., Kite, A Gilead Company, Peter MacCallum Cancer Centre, Australia, National Institute of Allergy and Infectious Diseases (NIAID)

Conditions

COVID-19CancerChronic Myelomonocytic Leukemia (CMML)Coronavirus Disease 2019 (COVID-19) PneumoniaCovid19Relapsed/Refractory Large B-cell LymphomaRespiratory Viral Infection

Phase 1

Study of Lenzilumab in Previously Treated Patients With Chronic Myelomonocytic Leukemia (CMML)
CompletedNCT02546284
Humanigen, Inc.Chronic Myelomonocytic Leukemia (CMML)
Start: 2016-07-31End: 2020-02-29Updated: 2020-02-28
Study of Lenzilumab and Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma
TerminatedNCT04314843
Kite, A Gilead CompanyRelapsed/Refractory Large B-cell Lymphoma
Start: 2020-05-26End: 2022-07-27Updated: 2024-03-04

Phase 2

ACTIV-5 / Big Effect Trial (BET-B) for the Treatment of COVID-19
CompletedNCT04583969
National Institute of Allergy and Infectious Diseases (NIAID)COVID-19
Start: 2020-10-23End: 2022-04-22Updated: 2023-06-05

Phase 3

Phase 3 Study to Evaluate Efficacy and Safety of Lenzilumab in Patients With COVID-19
NCT04351152
Humanigen, Inc.Coronavirus Disease 2019 (COVID-19) Pneumonia
Start: 2020-05-05End: 2021-03-31Updated: 2021-03-03
COVID-19 Prevention and Treatment in Cancer; a Sequential Multiple Assignment Randomised Trial;
CompletedNCT04534725
Peter MacCallum Cancer Centre, AustraliaCancer, Covid19, Respiratory Viral Infection
Start: 2020-12-17End: 2023-04-19Updated: 2023-08-24

Related Papers

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CAR-T State of the Art and Future Challenges, A Regulatory Perspective.
2023-07-2220 citations
1134. Lenzilumab Treatment in COVID-19 Pneumonia Reduces Circulating Cytokines and Markers of Systemic Inflammation
Open Forum Infectious Diseases2022-12-01
ZUMA-19: A Phase 1/2 Study of Axicabtagene Ciloleucel Plus Lenzilumab in Patients With Relapsed or Refractory Large B-Cell Lymphoma
Blood2022-11-1514 citations
C reactive protein utilisation, a biomarker for early COVID-19 treatment, improves lenzilumab efficacy: results from the randomised phase 3 ‘LIVE-AIR’ trial
Thorax2022-07-0611 citations
Lenzilumab in hospitalised patients with COVID-19 pneumonia (LIVE-AIR): a phase 3, randomised, placebo-controlled trial.
2021-12-0155 citations
S48 Lenzilumab efficacy and safety in newly hospitalized Covid-19 subjects: results from the LIVE-AIR phase 3 randomized double-blind placebo-controlled trial
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The dysregulated innate immune response in severe COVID-19 pneumonia that could drive poorer outcome
Journal of Translational Medicine2020-12-0176 citations
GM-CSF Neutralization With Lenzilumab in Severe COVID-19 Pneumonia: A Case-Cohort Study.
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