A Study of BN104 in the Treatment of Acute Leukemia
NCT06052813 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 66
Last updated 2026-02-25
Summary
The Phase I/II trial is to learn the safety, pharmacokinetics, and preliminary efficacy of BN104 taken once daily or twice daily in patients with acute lymphocytic leukemia or acute myeloblastic leukemia.
Conditions
- ALL, Adult
- AML, Adult
- Acute Leukaemia
- KMT2A Rearrangement
- NPM1 Mutation
- NUP98 Gene Rearrangement
- Menin Inhibitors
Interventions
- DRUG
-
BN104 monotherapy
Phase I(adults): Will be administered orally once daily (approximately every 24 hours) for the first cohort or twice daily (approximately every 12 hours) for the subsequent cohorts.
- DRUG
-
BN104 monotherapy
Phase I(adolescent): Will be administered orally twice daily (approximately every 12 hours)
- DRUG
-
BN104 monotherapy - rp2d
receiving oral BN104 treatment at a dose of 600 mg BID (300 mg BID when co-administered with strong CYP3A4 inhibitors)
Sponsors & Collaborators
-
Institut de Recherches Internationales Servier (I.R.I.S.)
lead INDUSTRY
Principal Investigators
-
Depei WU, Prof. · The First Affiliated Hospital of Soochow University
-
Mingyuan Sun, Dr. · Institute of Hematology, Chinese Academy of Medical Sciences
-
Yan Li, Dr. · Institute of Hematology, Chinese Academy of Medical Sciences
-
Xudong Wei, Prof. · Henan Oncology Hospital
-
Dengju Li, Prof. · Tongji Hospital
-
Yuhua Li, Prof. · Southern Medical University, China
-
Xiaoyu Zhu, Prof. · Anhui Provinvcal Hospital
-
Fei Li, Prof. · The First Affiliated Hospital of Nanchang University
-
Jinhai Ren, Prof. · The Second Hospital of Hebei Medical University
-
He Huang, Prof. · Zhejiang University
-
Pengcheng He, Prof. · First Affiliated Hospital Xi'an Jiaotong University
-
Wei Wang, Dr. · The Affiliated Hospital of Qingdao University
-
Yu Cao, Dr. · The Affiliated Hospital of Qingdao University
-
Songfu Jiang, Prof. · First Affiliated Hospital of Wenzhou Medical University
-
Jian Ge, Prof. · The First Affiliated Hospital of Anhui Medical University
-
Bei Liu, Dr. · LanZhou University
-
Yuping Gong, Prof. · West China Hospital
-
Xiaojun Xu, Prof. · Children's Hospital, Zhejiang University School of Medicine
-
Xiaofan Zhu, Prof. · Chinese Academy of Medical Sciences Haematological Diseases Hospital
-
Wenting Hu, Dr. · Shanghai Children's Medical Center
-
Meng LV, Dr. · Peking University People's Hospital
-
Jun Luo, Prof. · First Affiliated Hospital of Guangxi Medical University
-
Zhenfang Liu, Prof. · First Affiliated Hospital of Guangxi Medical University
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-10-19
- Primary Completion
- 2026-12-31
- Completion
- 2027-12-31
- FDA Drug
- Yes
Countries
- China
Study Locations
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