A Multicenter, Open Phase Ib Study of the Safety and Efficacy of BEBT-908 Combined With Drugs in the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma
This is a multicenter, open Phase Ib clinical study to evaluate the safety,efficacy and pharmacokinetics of BEBT-908 combined with Rituximab (R) or combined with Rituximab-Gemcitabine-Oxaliplatin (R-GemOx) or combined with Rituximab-Ifosfamide-Carboplatin-Etoposide (R-ICE) in the treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL).
• The subject is willing to sign the informed consent form (ICF) after comprehensive understanding;
• Age ≥18 years and ≤75 years, both male and female;
• The pathology was confirmed as diffuse large B-cell lymphoma according to the 2016 World Health Organization classification definition;
• Evaluation by Positron Emission Computed Tomography (PET-CT) or Computed Tomography (CT) or Magnetic resonance imaging (MRI) using Lugano 2014 standard, with measurable lesion injection;
• Must have recurrent or refractory diffuse large B-cell lymphoma after at least 1 systemic therapy, and at least 1 systemic therapy included CD20 antibody;
• Eastern Cooperative Oncology Group (ECOG) scores 0-2 points;
• Life expectancy \>12 weeks;
• The level of organ function must meet the following requirements:
⁃ Peripheral blood:
• Absolute neutrophil count (ANC) ≥1000/μL;
• Hemoglobin (HGB) ≥8g/dL;
• Platelet count (PLT) ≥100,000/μL;
⁃ Liver function:
• Serum total bilirubin ≤1.5×ULN (for patients with Gilbert syndrome, total bilirubin \<3.0×ULN and Direct bilirubin within normal range);
• Serum creatinine \<1.5×ULN;
• ALT, AST or ALP≤2.5×ULN (≤5×ULN when liver involvement occurs).