drugset / Trial / NCT07255872
A Study of BL-M11D1 in Combination With Cytarabine + Daunorubicin or Venetoclax + Azacitidine in Patients With Acute Myeloid Leukemia
Phase 2/3
Not yet recruiting
216 enrolled
Sichuan Baili Pharmaceutical Co., Ltd.
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd. · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2026-03
- Primary completion
- 2027-12
- Completion
- 2027-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BL-M11D1 | Unknown | — | Intravenous |
| Background | Azacitidine | Other / unclassified | — | — |
| Background | Cytarabine | Small molecule | — | — |
| Background | Daunorubicin | Small molecule | — | — |
| Background | Venetoclax | Small molecule | — | — |