A Study of BL-M11D1 in Combination With Cytarabine + Daunorubicin or Venetoclax + Azacitidine in Patients With Acute Myeloid Leukemia

A Phase II/III Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-M11D1 for Injection in Combination With Cytarabine + Daunorubicin or Venetoclax + Azacitidine in Patients With Acute Myeloid Leukemia

This study is an open, multicenter, dose-escalation and expansion, non-randomized phase II/III clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of BL-M11D1 in combination with cytarabine + daunorubicin or venetoclax + azacitidine in patients with acute myeloid leukemia.

The study cohorts include: Cohort A: Untreated newly diagnosed acute myeloid leukemia patients treated with BL-M11D1 in combination with cytarabine + daunorubicin. Cohort B: Untreated newly diagnosed acute myeloid leukemia patients treated with BL-M11D1 in combination with venetoclax + azacitidine.

Inclusion Criteria:

1. Voluntarily sign the informed consent form and comply with the protocol requirements;
2. No gender restrictions;
3. Age: ≥18 years;
4. Expected survival time ≥3 months;
5. Newly diagnosed AML according to the World Health Organization (WHO) 2016 classification and confirmed by morphology;
6. ECOG performance status score ≤2;
7. Peripheral blood white blood cell count ≤25×10⁹/L before the first dose;
8. Organ function levels must meet the requirements;
9. For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, and the serum/urine pregnancy test must be negative. Patients must not be breastfeeding; all enrolled patients (regardless of male or female) should adopt adequate barrier contraception throughout the entire treatment cycle and for 6 months after the end of treatment.

Exclusion Criteria:

1. Acute promyelocytic leukemia, acute transformation of chronic myeloid leukemia;
2. Previous treatment for AML;
3. Participation in other interventional or observational studies;
4. History of severe cardiovascular or cerebrovascular diseases within 6 months prior to screening;
5. Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block, frequent and uncontrollable arrhythmia;
6. Active autoimmune diseases and inflammatory diseases;
7. Diagnosis of other malignancies within 5 years prior to the first dose;
8. Poorly controlled hypertension;
9. Grade ≥3 lung disease as defined by CTCAE v5.0, history of interstitial lung disease requiring systemic steroid therapy, etc.;
10. Patients with central nervous system involvement;
11. Previous organ transplantation;
12. History of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient component of BL-M11D1;
13. Positive human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
14. Evidence of other clinically significant, poorly controlled infections requiring systemic treatment;
15. Clinically symptomatic or recurrent pleural, peritoneal, pelvic, or pericardial effusion requiring drainage;
16. Pregnant or lactating women;
17. Within 4 weeks prior to the first dose of the study drug, subjects must not have received any live vaccines or are not expected to receive live vaccines during the study participation;
18. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.