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A Randomized, Controlled, Open-label, Multicenter Phase 3 Clinical Study to Evaluate Lemzoparlimab for Injection in Combination With Azacitidine (AZA) Versus AZA Monotherapy in Treatment-naïve Patients With Higher-risk Myelodysplastic Syndrome (MDS)

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Trial Profile

A Randomized, Controlled, Open-label, Multicenter Phase 3 Clinical Study to Evaluate Lemzoparlimab for Injection in Combination With Azacitidine (AZA) Versus AZA Monotherapy in Treatment-naïve Patients With Higher-risk Myelodysplastic Syndrome (MDS)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 17 Apr 2024

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At a glance

  • Drugs Azacitidine (Primary) ; Lemzoparlimab (Primary)
  • Indications Myelodysplastic syndromes
  • Focus Registrational; Therapeutic Use
  • Sponsors I-MAB Biopharma

    • Most Recent Events

    • 24 Apr 2023 According to an I-Mab Biopharma media release, the first patient has been dosed and treated in the study.
    • 07 Apr 2023 Status changed from not yet recruiting to recruiting.
    • 13 Sep 2022 According to an I-Mab Biopharma media release, the company announced that it has successfully completed an End-of-Phase 2 (EoP2) meeting with the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA), and has obtained approval from the CDE to initiate this study, The EoP2 meeting was supported by encouraging results from the Phase 2 clinical trial evaluating lemzoparlimab in combination with AZA in patients with newly diagnosed HR-MDS (NCT04202003)

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