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

NCT07255872 | Not Yet Recruiting Phase 2

• 1 other identifier: BL-M11D1-201
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (3)

• Objective Response Rate (ORR)

  ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1.

  Up to approximately 24 months

• Composite Response Rate（CRc）

  CRc is defined as the proportion of patients who achieve any one of several pre-defined types of treatment response.

  Up to approximately 24 months

• Phase IIa: Recommended Phase II Dose (RP2D)

  The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of BL-M11D1.

  Up to approximately 24 months

Secondary Outcomes (8)

• Progression-free survival (PFS)

  Up to approximately 24 months

• Disease Control Rate (DCR)

  Up to approximately 24 months

• Relapse-Free Survival (RFS)

  Up to approximately 24 months

• Treatment-Emergent Adverse Event (TEAE)

  Up to approximately 24 months

• Cmax

  Up to approximately 24 months

Study Arms (1)

BL-M11D1 in Combination with Cytarabine + Daunorubicin or Venetoclax + Azacitidine

EXPERIMENTAL

Participants receive BL-M11D1 in Combination with Cytarabine + Daunorubicin or Venetoclax + Azacitidine for the first cycle (4 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.

Drug: BL-M11D1; Drug: Cytarabine; Drug: Daunorubicin; Drug: Venetoclax; Drug: Azacitidine

Interventions

BL-M11D1 DRUG

Administration by intravenous infusion for a cycle of 4 weeks.

BL-M11D1 in Combination with Cytarabine + Daunorubicin or Venetoclax + Azacitidine

Cytarabine DRUG

Administration in 4-week cycles.

BL-M11D1 in Combination with Cytarabine + Daunorubicin or Venetoclax + Azacitidine

Daunorubicin DRUG

Administration in 4-week cycles.

BL-M11D1 in Combination with Cytarabine + Daunorubicin or Venetoclax + Azacitidine

Venetoclax DRUG

Administration in 4-week cycles.

BL-M11D1 in Combination with Cytarabine + Daunorubicin or Venetoclax + Azacitidine

Azacitidine DRUG

Administration in 4-week cycles.

BL-M11D1 in Combination with Cytarabine + Daunorubicin or Venetoclax + Azacitidine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Acute promyelocytic leukemia, acute transformation of chronic myeloid leukemia;
• Previous treatment for AML;
• Participation in other interventional or observational studies;
• History of severe cardiovascular or cerebrovascular diseases within 6 months prior to screening;
• Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block, frequent and uncontrollable arrhythmia;
• Active autoimmune diseases and inflammatory diseases;
• Diagnosis of other malignancies within 5 years prior to the first dose;
• Poorly controlled hypertension;
• Grade ≥3 lung disease as defined by CTCAE v5.0, history of interstitial lung disease requiring systemic steroid therapy, etc.;
• Patients with central nervous system involvement;
• Previous organ transplantation;
• 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;
• Clinically symptomatic or recurrent pleural, peritoneal, pelvic, or pericardial effusion requiring drainage;

Sponsors & Collaborators

• Sichuan Baili Pharmaceutical Co., Ltd.: lead
• Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Cytarabine; Daunorubicin; venetoclax; Azacitidine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Aza Compounds; Ribonucleosides

Central Study Contacts

Sa Xiao, PHD

CONTACT

15013238943; xiaosa@baili-pharm.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 1, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

CN (1)