BL-M11D1 added to standard chemotherapy drugs for acute myeloid leukemia

Trial details

Who runs it

Sichuan Baili Pharmaceutical Co., Ltd.

Trial code

NCT07255872

Record updated

10 September 2026

Original description

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.Read full original descriptionShow less

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.

Inclusion: Voluntarily sign the informed consent form and comply with the protocol requirements; No gender restrictions; Age: ≥18 years; Expected survival time ≥3 months; Newly diagnosed AML according to the World Health Organization (WHO) 2016 classification and confirmed by morphology; ECOG performance status score ≤2; Peripheral blood white blood cell count ≤25×10⁹/L before the first dose; Organ function levels must meet the requirements; 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: Previous treatment for AML; History of severe cardiovascular or cerebrovascular diseases within 6 months prior to screening; Diagnosis of other malignancies within 5 years prior to the first dose; Previous organ transplantation; 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; Active autoimmune diseases and inflammatory diseases; Poorly controlled hypertension; Grade ≥3 lung disease as defined by CTCAE v5.0, history of interstitial lung disease requiring systemic steroid therapy, etc; History of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient component of BL-M11D1; Positive human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection; Evidence of other clinically significant, poorly controlled infections requiring systemic treatment; Other conditions deemed by the investigator as unsuitable for participation in this clinical trial; Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block, frequent and uncontrollable arrhythmia; Acute promyelocytic leukemia, acute transformation of chronic myeloid leukemia; Participation in other interventional or observational studies; Patients with central nervous system involvement; Clinically symptomatic or recurrent pleural, peritoneal, pelvic, or pericardial effusion requiring drainage; Pregnant or lactating women.

ClinicalTrials.gov NCT07255872