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

Inclusion Criteria

• •Voluntarily participate in the study and sign the informed consent;
• •18≤age≤75，Men or women；
• •AML patients (except acute promyelocytic leukemia) : subjects who meet the diagnostic criteria for relapsed/refractory AML according to the diagnostic criteria of 2021 Chinese Guidelines for the Diagnosis and Treatment of Relapsed and Refractory AML ； MDS patients: MDS patients were diagnosed as having moderate risk of recurrence/refractory (IPSS-R score \>3.5) according to WHO diagnostic criteria in 2016
• •ECOG:0-2;
• •Survival expectation of at least 3 months;
• •Adequate organs and hematopoietic functions; only applicable for phase II :
• •Newly diagnosed AML with intolerance to standard induction chemotherapy who should meet one of following criterias: age ≥75 years; ECOG 2-3; chronic heart failure requiring treatment or EF≤50% or chronic stable angina pectoris; DLCO≤65% or FEV1≤65%;30ml/min≤CrCl\<45ml/min；1.5 x ULN\<total bilirubin≤3.0 x ULN
• •Newly diagnosed intermediate- and high-risk (International Prognostic Scoring System IPSS-R) MDS