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)
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Peripheral T Cell Lymphoma
- Sponsor
- Genor Biopharma Co., Ltd.
- Enrollment
- 86
- Locations
- 1
- Primary Endpoint
- Objective response rate, ORR
- Last Updated
- 5 years ago
Overview
Brief 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
Investigators
Eligibility Criteria
Inclusion Criteria
- •Aged 18 years or older, male or female;
- •Understand study procedures and contents, and voluntarily sign the written informed consent form;
- •Histologically confirmed relapsed or refractory PTCL patients who had received systemic treatment at least once but had failed to or cannot tolerate the treatment, and/or who cannot be treated with effective standard therapies currently.
- •Available to provide tissue sample for pathological diagnosis;
- •ECOG score of 0-1;
- •Life expectancy≥3 months;
- •Computed tomography (ct) scans performed within 28 days of study administration should show the presence of at least one of two vertical orientationsThe tumor lesions that could be measured were defined, with the longest diameter of intranode lesion \> 1.5cm and the longest diameter of extranode lesion \> 1.0cm (according to2014 lugano standard)
- •Systemic chemotherapy, systemic or local palliative radiotherapy, target therapy has been completed for at least 4 weeks before enrollment.
- •Systemic corticosteroids (prednisone \> 10 mg/day or equivalent dose) has been discontinued at least 2 weeks before enrollment;
- •Autologous hematopoietic stem cell transplantation (ASCT) has been completed at least 4 weeks before enrollment;
Exclusion Criteria
- •Diagnosed as vascular immunoblastic t-cell lymphoma (AITL) or adult t-cell lymphoma/leukemia(ATLL);
- •Defined central nervous system (CNS) infiltration of lymphoma, including brain parenchyma, meningeal infringement or spinal cord compression;
- •Previous history of organ transplantation or allogeneic hematopoietic stem cell transplantation;
- •Patients who have active, known or suspected autoimmune diseases;
- •Patients who were previously treated with anti PD-1 antibody, anti PD-L1 antibody, anti PD-L2 antibody or anti CTLA-4 antibody (or any other antibodies acting on T cell co-stimulation or checkpoint pathway);
- •Complicated with other serious internal diseases, including but not limited to uncontrolled diabetes mellitus, active gastrointestinal ulcers, active hemorrhage, etc.;
- •Received treatment with other study drugs within 30 days before administration of the study drug or before 5 half-lives of other study drugs (whichever is shorter); or use of investigational medical device within 30 days;
- •Patients with active pulmonary tuberculosis; patients who previously had active pulmonary tuberculosis;
- •Any of the following is positive: hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), acquired immunodeficiency syndrome antibody (Anti-HIV) and anti-treponema pallidum antibody (TP-Ab);
- •Patients with complications requiring treatment with immunosuppressive drugs or systemic or local corticosteroids at the immunosuppressive doses;
Outcomes
Primary Outcomes
Objective response rate, ORR
Time Frame: up to 2 years
To evaluate the efficacy of GB226 as defined by objective response rate in Chinese patients with recurrent or refractory PTCL
Secondary Outcomes
- Overall survival, OS(up to 2 years)
- Duration of response, DOR(up to 2 years)
- Progression-free survival, PFS(up to 2 years)
- Disease control rate (DCR)(up to 2 years)
- Time to response,TTR(up to 2 years)
- Antidrug antibody(up to 2 years)
- Adverse Effect (AE)(up to 2 years)