Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Peripheral T-cell Lymphoma

All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Geptanolimab Injection, 3mg/kg every 2 weeks

GB226

Shawn Yu, Master

Yuankai Shi, Doctor

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

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)

There is not a plan to make individual participant data available.

To evaluate the efficacy of GB226 as defined by objective response rate in Chinese patients with recurrent or refractory PTCL

To evaluate the duration of response (DOR) of GB226 in Chinese patients with recurrent or refractory PTCL

To evaluate the duration from the first administration to death because of any reason in Chinese patients with recurrent or refractory PTCL

To evaluate the efficacy of GB226 as defined by progression-free survival, in Chinese patients with recurrent or refractory PTCL

To evaluate the efficacy of GB226 as defined by disease control rate, inChinese patients with recurrent or refractory PTCL

To evaluate the efficacy of GB226 as defined by time to response in Chinese patients with recurrent or refractory PTCL

To evaluate the immunogenicity of GB226 in Chinese patients with recurrent or refractory PTCL

To evaluate the adverse effect of GB226 in Chinese patients with recurrent or refractory PTCL

Genor Biopharma Co., Ltd.

Symptoms and General Pathology

Recurrence

Lymphoma, B-Cell

B-cell Lymphoma

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

Clinical Trial in Chinese Patients of B-cell Non-Hodgkin's Lymphoma(GB226)

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)

To evaluate the efficacy of GB226 as defined by objective response rate, in patients with B-NHL.

To evaluate the duration of response (DOR) of GB242 in patients with B-NHL.

To evaluate the duration from the first administration to death because of any reason in patients with B-NHL.

To evaluate the efficacy of GB226 as defined by progression-free survival, in patients with B-NHL.

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Pharmaceutical Solutions

Geptanolimab Injection,3mg/kg once per 2 weeks

GB226 is administrated at the dose of 3mg/kg, once per 2 weeks (±3 days), and distributed in 100ml of 0.9% sodium chloride solution. The concentration of GB226 shall be strictly controlled at 1mg/ml\~10mg/ml, the duration is 60 min (±10 min) for the first infusion of the drug, and can be reduced to 30 min (±10 min) for the subsequent infusion of the drug if there is infusion related adverse reaction.

Shawn Yu, master

Lingying Wu

Wu Lingying, Medical PhD

Lingying Wu, Doctor

This study is a multi-center, prospective, open-label, single-arm phase II clinical study to evaluate the efficacy, safety and immunogenicity of GB226 in treatment of recurrent or metastatic cervical cancer patients with PD-L1 positive who failed in platinum-based chemotherapy.

A Study in Recurrent or Metastatic Cervical Cancer Patients With PD-L1 Positive

Phase II Clinical Study to Evaluate the Efficacy and Safety of GB226 in Treatment of Recurrent or Metastatic Cervical Cancer Patients With PD-L1 Positive Who Failed in Platinum-based Chemotherapy

To evaluate the efficacy of GB226 as defined by objective response rate, in patients with recurrent or metastatic cervical cancer.

To evaluate the efficacy of GB226 as defined by overall response rate, in patients with recurrent or metastatic cervical cancer.

To evaluate the efficacy of GB226 as defined by time to response in patients with recurrent or metastatic cervical cancer.

To evaluate the duration of response (DOR) of GB242 in patients with recurrent or metastatic cervical cancer.

To evaluate the efficacy of GB226 as defined by progression-free survival, in patients with recurrent or metastatic cervical cancer.

To evaluate the duration from the first administration to death because of any reason in patients with recurrent or metastatic cervical cancer.

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Fruquintinib, 3mg or 4mg or 5mg, qd.po. 3 weeks-on,1 week-off

Fruquintinib

shun lu, doctor

Shun Lu, Doctor

This study is a multi-center, open-label, dose-finding phase Ib clinical study with extension phase, which is aimed at evaluating the efficacy and safety of GB226 combined with fruquintinib in treatment of relapsed or metastatic NSCLC patients with EGFR-sensitive mutations who have failed to respond to EGFR-TKI treatment,evaluating the pharmacokinetic characteristics of GB226 and fruquintinib, and the immunogenicity of GB226, and preliminarily evaluating the antitumor activity of GB226 and fruquintinib.

In this study, it is planned to enroll at least 42 NSCLC patients who meet relevant criteria. This study includes dose escalation phase and extension phase of the combined therapy: three combined dose groups are planned in the dose escalation phase; the dose extension phase is divided into two cohorts.

Safety and Efficacy of Genolimzumab (GB226) in Combination With Fruquintinib

A Phase Ib Clinical Study With Extension Phase to Evaluate Safety and Efficacy of Genolimzumab (GB226) in Combination With Fruquintinib in the Treatment of Relapsed or Metastatic NSCLC Patients

Assessment of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v4.03

Assessment of serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v4.03

Defined as the highest dose tested in which only 0 or 1 out of 6 evaluable patients experience a dose limiting toxicity, as graded by the National Cancer Institute (NCI) Common terminology Criteria for Adverse Events (CTCAE) version 4.03

To evaluate the efficacy of GB226 as defined by objective response rate in patients with lung cancer.

To evaluate the efficacy of GB226 as defined by disease control rate in patients with lung cancer.

To evaluate the duration of response (DOR) of GB226 in patients with lung cancer

To evaluate the efficacy of GB226 as defined by progression-free survival in patients with lung cancer

To evaluate the efficacy of GB226 as defined by overall survival in patients with lung cancer.

To evaluate the immunogenicity of GB226 in Chinese patients with lung cancer.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clinical Trial in Chinese Patients of Relapsed and Refractory Peripheral T Cell Lymphoma (GB226)	NCT03502629	Peripheral T Ce...	GB226	18 Years -	Genor Biopharma Co., Ltd.
Clinical Trial in Chinese Patients of B-cell Non-Hodgkin's Lymphoma(GB226)	NCT03639181	B-cell Non-Hodg...	GB226	18 Years -	Genor Biopharma Co., Ltd.
Clinical Trial in Chinese Patients of B-cell Non-Hodgkin's Lymphoma(GB226)	NCT03639181	B-cell Non-Hodg...	GB226	18 Years -	Genor Biopharma Co., Ltd.
A Study in Recurrent or Metastatic Cervical Cancer Patients With PD-L1 Positive	NCT03808857	Cervical Cancer	GB226	18 Years -	Genor Biopharma Co., Ltd.
Safety and Efficacy of Genolimzumab (GB226) in Combination With Fruquintinib	NCT03976856	Metastatic Non-...	GB226 Fruquintinib	18 Years - 75 Years	Genor Biopharma Co., Ltd.
A Study in Recurrent or Metastatic Cervical Cancer Patients With PD-L1 Positive	NCT03808857	Cervical Cancer	GB226	18 Years -	Genor Biopharma Co., Ltd.
Clinical Trial in Chinese Patients of Relapsed and Refractory Peripheral T Cell Lymphoma (GB226)	NCT03502629	Peripheral T Ce...	GB226	18 Years -	Genor Biopharma Co., Ltd.

Spots Global Cancer Trial Database for gb226

Every month we try and update this database with for gb226 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for gb226

Every month we try and update this database with for gb226 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for gb226 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.