New hope for leukemia patients: experimental drug combo enters late-stage trial

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.