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A Multicenter, Open-label, Phase 1/2a Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of TJ011133 as Monotherapy and in Combination With Azacitidine (AZA) in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

Trial Profile

A Multicenter, Open-label, Phase 1/2a Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of TJ011133 as Monotherapy and in Combination With Azacitidine (AZA) in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 17 Apr 2024

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At a glance

  • Drugs Azacitidine (Primary) ; Lemzoparlimab (Primary)
  • Indications Acute myeloid leukaemia; Myelodysplastic syndromes
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors I-MAB Biopharma

Most Recent Events

  • 25 Feb 2024 Status changed from active, no longer recruiting to completed.
  • 30 Jan 2024 Planned End Date changed from 1 Feb 2024 to 31 Dec 2024.
  • 30 Jan 2024 Planned primary completion date changed from 1 Oct 2023 to 31 Dec 2024.

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