drugset / Trial / NCT06074107

Study of BEBT-908 in the Relapsed or Refractory Diffuse Large B-cell Lymphoma Subjects

NCT06074107

Phase 2 Unknown 128 enrolled BeBetter Med Inc
NaSingle-groupOpen-labelTreatment

Summary

This is an open,single-arm,multicenter phase II clinical study to evaluate the efficacy and safety of BEBT-908 for injection in the treatment of relapsed or refractory diffuse large B-cell lymphoma. The study will be divided into two stages: phase Ⅱa and phase Ⅱb. Phase Ⅱa is an exploratory study, which mainly explores the safe and effective dose and the relationship between gene and protein markers and drug sensitivity. The main purpose of the phase Ⅱb study was to evaluate the Objective response rate of BEBT-908 for injection in the treatment of relapsed or refractory diffuse large B-cell lymphoma, and the secondary study was to evaluate the disease control rate, progression-free survival, time to response, duration of response, overall survival and safety tolerance of BEBT-908 for injection in the treatment of relapsed or refractory diffuse large B-cell lymphoma. The relationship between the biomarkers of BEBT-908 for injection and the efficacy and safety was evaluated.

Timeline

Start
2020-06-12
Primary completion
2023-12-20
Completion
2023-12-25

Drugs

EvaluationDrugModalityDoseRoute
Subject BEBT-908 Unknown 22.5 mg/m2 Intravenous