BL-M11D1 in combination with chemotherapy or venetoclax-based therapy for newly diagnosed AML

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open, multicenter, dose-escalation and expansion study evaluating BL-M11D1 added to either cytarabine plus daunorubicin or venetoclax plus azacitidine in adults with newly diagnosed AML. The study will enroll cohorts to determine safety, tolerability, and pharmacokinetics, with early look at efficacy in both treatment backbones. It is non-randomized and aims to identify a recommended dose for future trials. Patients will be followed for treatment response and adverse events at multiple time points during and after therapy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Study coordinator: Sa Xiao, PHD
• Email: xiaosa@baili-pharm.com
• Phone: 15013238943

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.