BN104 in Combination With Chemotherapy or Targeted Agents for Acute Myeloid Leukemia
ConditionAcute Myeloid Leukemia
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorChen Suning
About this trial
The Phase I/II trial is to learn the safety, pharmacokinetics, and preliminary efficacy of BN104 taken twice daily combined with Intensive Chemotherapy or Venetoclax/Azacitidine in patients with acute myeloblastic leukemia.
Eligibility criteria
Qualifiers
Have been fully informed about the study and have voluntarily signed the ICF;
Patients with newly diagnosed primary AML according to the 2022 World Health Organization (WHO) criteria (Groups A and B) or patients with relapsed/refractory AML who have been previously treated with menin inhibitor monotherapy (Group C) and have an intermediate or poor prognosis according to the 2022 ELN Risk Stratification, as well as a defined combination of NPM1 mutation or NUP98 rearrangement or KMT2A rearrangement
Peripheral blood leukocyte count ≤ 25 x 109/L (limited to patients enrolled in groups B and C, where hydroxyurea is allowed to control peripheral blood leukocyte count)
Aged 18 years or older;
Disqualifiers
have active central nervous system (CNS) leukemia;
a known history of clinically significant liver disease, including viral or other hepatitis or cirrhosis:Positive hepatitis B surface antigen (HBsAg) serology requires a negative hepatitis B virus (HBV) DNA test for enrollment; For patients with hepatitis C virus (HCV) antibody serology positive, a negative HCV RNA test result is required for enrollment.
known human immunodeficiency virus (HIV) infection;
pregnant (positive screening pregnancy test) or lactating females;
Trial design
Treatments tested in this trial
- BN104 combined Intensive Chemotherapy or Venetoclax/Azacitidine
Treatment groups
135 Participants
are divided into 3 treatment groupsSponsors and collaborators
Chen Suning
Lead sponsor
The First Affiliated Hospital of Soochow University
Sponsor institution
BioNova Pharmaceuticals (Shanghai) LTD.
Collaborator
Source ClinicalTrials.gov