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.
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
86
3mg/kg treat every 2 weeks
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGObjective response rate, ORR
To evaluate the efficacy of GB226 as defined by objective response rate in Chinese patients with recurrent or refractory PTCL
Time frame: up to 2 years
Duration of response, DOR
To evaluate the duration of response (DOR) of GB226 in Chinese patients with recurrent or refractory PTCL
Time frame: up to 2 years
Overall survival, OS
To evaluate the duration from the first administration to death because of any reason in Chinese patients with recurrent or refractory PTCL
Time frame: up to 2 years
Progression-free survival, PFS
To evaluate the efficacy of GB226 as defined by progression-free survival, in Chinese patients with recurrent or refractory PTCL
Time frame: up to 2 years
Disease control rate (DCR)
To evaluate the efficacy of GB226 as defined by disease control rate, inChinese patients with recurrent or refractory PTCL
Time frame: up to 2 years
Time to response,TTR
To evaluate the efficacy of GB226 as defined by time to response in Chinese patients with recurrent or refractory PTCL
Time frame: up to 2 years
Antidrug antibody
To evaluate the immunogenicity of GB226 in Chinese patients with recurrent or refractory PTCL
Time frame: up to 2 years
Adverse Effect (AE)
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To evaluate the adverse effect of GB226 in Chinese patients with recurrent or refractory PTCL
Time frame: up to 2 years