Ifupinostat Hydrochloride

This is a single-center, open-label, exploratory study evaluating ifupinostat hydrochloride (BEBT-908) in patients with B-cell precursor acute lymphoblastic leukemia (BCP-ALL) with MEF2D rearrangement. The study will include patients with relapsed or refractory disease and patients who are in morphologic remission but still have measurable residual disease (MRD). The main purpose of the study is to evaluate the preliminary anti-leukemia activity of BEBT-908 in patients with relapsed or refractory disease and its ability to reduce or eliminate residual leukemia in patients with MRD-positive disease. The study will also assess the depth and duration of response, survival outcomes, subsequent treatment such as stem cell transplantation or CAR-T therapy, and the safety and tolerability of BEBT-908. Approximately 10 to 15 participants aged 14 to 75 years are planned to be enrolled. All participants will receive BEBT-908 by intravenous infusion at 18.5 mg/m² on Days 1, 3, 5, 8, 10, and 12 of each 21-day cycle for up to two cycles. Bone marrow morphology, flow cytometry MRD, and MEF2D fusion transcript levels will be evaluated during the study to assess treatment response.