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RECRUITING
NCT07854652
PHASE1

BEBT-908 in MEF2D-Rearranged Relapsed/Refractory or MRD-Positive B-Cell Precursor Acute Lymphoblastic Leukemia

Sponsor: The First Affiliated Hospital of Soochow University

View on ClinicalTrials.gov

Summary

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.

Official title: An Exploratory Clinical Study of Ifupinostat Hydrochloride for Injection (BEBT-908) Monotherapy in Relapsed/Refractory or Measurable Residual Disease-Positive B-Cell Precursor Acute Lymphoblastic Leukemia With MEF2D Rearrangement

Key Details

Gender

All

Age Range

14 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2026-09-01

Completion Date

2030-08-30

Last Updated

2026-10-02

Healthy Volunteers

No

Interventions

DRUG

Ifupinostat Hydrochloride

Ifupinostat hydrochloride (BEBT-908) will be administered intravenously at a dose of 18.5 mg/m² on Days 1, 3, 5, 8, 10, and 12 of each 21-day cycle for up to 2 cycles. Each dose will be administered as a constant-rate intravenous infusion over 30 ± 5 minutes.

Locations (1)

The first affiliated hospital of soochow university

Suzhou, China