A Study of BN104 in the Treatment of Acute Leukemia

Inclusion criteria

• ✓. Have been fully informed about the study and have voluntarily signed the ICF;
• ✓. Patients diagnosed with relapsed/refractory acute leukaemia (including AML, ALL, and mixed-phenotype acute leukaemia, excluding acute promyelocytic leukaemia) according to the World Health Organization (WHO) criteria in 2022, with bone marrow morphological changes (blasts/immature cells ≥ 5%), and who have been evaluated by the investigator to have no better treatment options, must meet at least one of the following conditions:
• ✓. For all Phase I patients, the presence of NPM1 mutation, or KMT2A rearrangement, or NUP98 rearrangement must be confirmed,During Phase I, patients with other acute leukemia subtypes shown to depend on menin-KMT2A interaction (e.g., UBTF-TD) or driven by HOXA/MEIS1 overexpression may also be eligible after consultation with the Sponsor's Medical Monitor;
• ✓. Patients in the Phase II (single-arm pivotal clinical study) must have a confirmed NPM1 mutation or KMT2A rearrangement. Enrollment based on local testing results is acceptable with a copy of the test report provided; however, all patients are required to submit screening bone marrow samples to the central laboratory ,Eligible NPM1 mutations include exon12 type A, B, and D mutations ; other NPM1 mutations causing cytoplasmic localization require sponsor pre-approval for enrollment. KMT2A rearrangements exclude non-fusion rearrangements involving KMT2A partial tandem duplication (KMT2A-PTD).
• ✓. Peripheral blood white blood cell count ≤ 35 × 109/L (use of hydroxyurea to control peripheral white blood cell count is permitted);
• ✓. Age ≥ 12 years (for adolescent patients aged 12 years or older but not yet 18 years old, weight must be ≥ 40 kg);
• ✓. ECOG score 0-2;
• ✓. Adequate hepatic, renal, and cardiac functions

Exclusion criteria