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

StatusRecruiting
PhasePhase 2/3
Started2026-04-02
View on ClinicalTrials.gov ↗

Amendment history

2026-09-08
Study Status, Contacts/Locations v2
Recruitment opened
Start dateestimated 2026-03→confirmed 2026-04-02
Study sitesdetails revised at 1 of 1 site
2026-03-03
Study Identification, Study Status, Study Description, Study Design, Outcome Measures, Eligibility v1
Start date2025-12→2026-03
Enrollment target80→216
Eligibility criteria-90 characters
[...] toneal, pelvic, or pericardial effusion requiring drainage; Previous treatment with cytarabine, methylating agents, or investigational drugs for MDS; Pregnant or lactating women; Within 4 weeks prior to the fir [...]
Secondary endpoints4 to 8 entries
Cmax Tmax Ctrough ADA (anti-drug antibody)
Study title-16 characters
A Study of BL-M11D1 in Combination With Cytarabine + Daunorubicin or Venetoclax + Azacitidine in Patients With Newly Diagnosed Acute Myeloid Leukemia
2025-11-20
Original filing
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.
Trial Details
NCT Number NCT07255872
Lead Sponsor Sichuan Baili Pharmaceutical Co., Ltd.
Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Conditions Acute Myeloid Leukemia
Enrollment 216 participants
Start Date 2026-04-02
Primary Completion 2027-12 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-09-10