Evaluate the Safety, Tolerability, Pharmacokinetic Profile, Efficacy of Bl-M11D1

Inclusion criteria

• . Signed the informed consent
• . Age ≥18 years
• . Has a life expectancy of ≥3 months
• . Relapsed and/or refractory CD33-positive AML as determined by local pathology review that has failed initial standard of care therapy. Diagnosis of primary AML or AML secondary to myelodysplastic syndromes. Relapsed or refractory status. CD33-positive as confirmed by local flow cytometry or cytology
• . Has an Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 2
• . Toxicity of previous anticancer therapy has returned to Grade ≤1 as defined by NCI CTCAE V5.0, except for alopecia and endocrinopathies controlled by replacement therapy that must be Grade ≤2
• . Has adequate liver and renal function before registration, defined as: a. Hepatic function: Total bilirubin (TBIL) ≤1.5×ULN (≤3×ULN for subjects with Gilbert's syndrome), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN b. Renal function: Creatinine clearance ≥50 mL/min (Cockcroft-Gault, Chronic Kidney Disease Epidemiology Collaboration \[CKD-Epi\], or Modification of Diet in Renal Disease Study \[MDRD\] equations)
• . Sexually active fertile subjects and their partners must agree to use highly effective methods of contraception during the course of the study and for 7 months after the last dose of study treatment. An additional contraceptive method, such as a barrier method (eg, condom), is recommended

Exclusion criteria