B-cell Non-Hodgkin's Lymphoma Clinical Trial
Official title:
A Study to Evaluate the Efficacy and Safety of Genormab Injection in Chinese Patients With Recurrent or Refractory B-cell Non-Hodgkin's Lymphoma (B-NHL)
An open-label, single-arm, phase II clinical study of anti-PD-1 antibody GB226 in treatment of recurrent or refractory B-cell non-Hodgkin's lymphoma (B-NHL)
GB226, 3mg/kg/time, is intravenously infused once every two weeks until disease progression, intolerable toxicity or study withdrawal decided by the investigator/subject. It is expected that each subject will be followed for 2 years. Subjects receiving GB226 treatment will be followed once every 2 weeks to the end of this study. If the patients terminate the treatment and their imaging assessment shows no progressive disease (PD), they should be followed once every 6 weeks until progressive disease (imaging evaluation). If the patients have progressive disease (imaging assessment), they should be followed every 3 months until the end of this study or premature withdrawal from the study. Relevant tests and evaluation should be completed at each visit according to standard of care. The follow-up visits can be performed by telephone. During the study, subjects must complete one imaging test and efficacy evaluation every 6 weeks until disease progression. Moreover, patients should be closely monitored for adverse events from subject enrollment to 30 days after the last dosing ;
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