NCT03502629

Clinical Trial in Chinese Patients of Relapsed and Refractory Peripheral T Cell Lymphoma (GB226)

A Phase II Clinical Study to Evaluate the Efficacy and Safety of GB226 for the Treatment of Chinese Population With Relapsed and Refractory Peripheral T Cell Lymphoma (PTCL)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 86 (estimated)
• Sponsor: Genor Biopharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

It is a multi-center, prospective, open-label, two-stage optimized design, single-arm, phase II clinical study to evaluate the efficacy and safety of GB226 for the treatment of relapsed and refractory peripheral T cell lymphoma (PTCL), and to evaluate the immunogenicity of GB226.

Detailed description

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

Conditions

• Peripheral T Cell Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	GB226	3mg/kg treat every 2 weeks

Timeline

• Start date: 2018-07-02
• Primary completion: 2021-08-01
• Completion: 2022-12-30
• First posted: 2018-04-18
• Last updated: 2021-03-03

Locations

1 site across 1 country: China