Spots Global Cancer Trial Database for A Clinical Study of 6MW3211 Monotherapy or Combination Therapy for AML or MDS

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Trial Identification

Brief Title: A Clinical Study of 6MW3211 Monotherapy or Combination Therapy for AML or MDS

Official Title: A Study to Evaluate Pharmcokinetics, Pharmacodynamics , Efficacy and Safety of 6MW3211 Monotherapy and in Combination With Azacitidine(AZA) or AZA Plus Venetoclax(VEN) in Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

Study ID: NCT05448599

Conditions

Acute Myeloid Leukemia

Myelodysplastic Syndrome

Interventions

6MW3211 injection with Intravenous Infusion

Study Description

Brief Summary: This study is aimed to evaluate the efficacy, safety, immunogenicity and pharmkinetics, pharmacodynamics of 6MW3211 as monotherapy and in combination with AZA or AZA plus VEN in patients with AML/MDS.

Detailed Description: This study is a phase I/II study to evaluate the pharmacokinetics, pharmacodynamics, efficacy and safety of 6MW3211 monotherapy or combined with AZA or AZA plus VEN in patients with AML and MDS. There will be 2 parts of this study. The phase Ib is about monotherapy of 6MW3211 and Phase II is designed to evaluate the safety and efficacy of 6MW3211 combined with AZA or AZA plus VEN in patients with relapse/refractory and newly diagnosed AML and MDS.