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

NCT03502629 | Unknown Phase 2

• 1 other identifier: Gxplore-002
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral T Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate, ORR

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

  up to 2 years

Secondary Outcomes (7)

• Duration of response, DOR

  up to 2 years

• Overall survival, OS

  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

Study Arms (1)

GB226 3mg/kg every 2 weeks

EXPERIMENTAL

Geptanolimab Injection, 3mg/kg every 2 weeks

Biological: GB226

Interventions

GB226 BIOLOGICAL

3mg/kg treat every 2 weeks

Also known as: Recombinant humanized anti-PD-1 monoclonal antibody injection, Geptanolimab

GB226 3mg/kg every 2 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Before enrollment, major surgery requiring general anesthesia must have been completed at least 4 weeks; surgery requiring local anesthesia/epidural anesthesia must have been completed at least 2 weeks and the patients have recovered; skin biopsy requiring local anesthesia has been completed at least 1 hour.
• The previous anti-tumor biotherapy (tumor vaccine aimed at controlling tumor, cytokine or growth factor) has been completed at least 4 weeks before enrollment.
• For routine blood tests: hemoglobin ≥ 80 g/L, neutrophil ≥ 1.0 ×109/L, platelet ≥ 80×109/L;
• Serum creatinine ≤ 1.5×ULN or creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula);
• Total bilirubin \< 1.5 times the upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.5 times the upper limit of normal (ULN);

You may not qualify if:

• 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;
• 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 receiving any anti-infection vaccine (e.g. influenza vaccine, varicella vaccine etc.) within 4 weeks before enrollment;
• Patients with symptomatic pleural, peritoneal and pericardial effusion;
• Patients with drug abuse history or alcohol addiction history;
• Uncontrollable or symptomatic dropsy of serous cavity, e.g. ascites, pleural effusion or pericardial effusion;

Sponsors & Collaborators

• Genor Biopharma Co., Ltd.: lead

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

Related Publications (2)

• Lou N, Yang M, Xie Z, Gao R, Zhang L, Tang L, Yao J, Han X, Shi Y. JAK3 A573V and JAK3 M511I mutations in peripheral T-cell lymphoma mediating resistance to anti-PD-1 therapy through the STAT3/PD-L1 pathway. J Immunother Cancer. 2025 Apr 8;13(4):e010783. doi: 10.1136/jitc-2024-010783.

  PMID: 40199606 DERIVED

• Shi Y, Wu J, Wang Z, Zhang L, Wang Z, Zhang M, Cen H, Peng Z, Li Y, Fan L, Guo Y, Ma L, Cui J, Gao Y, Yang H, Zhang H, Wang L, Zhang W, Zhang H, Xie L, Jiang M, Zhou H, Shuang Y, Su H, Ke X, Jin C, Du X, Du X, Liu L, Xi Y, Ge Z, Feng R, Zhang Y, Zhou S, Xie F, Wang Q. Efficacy and safety of geptanolimab (GB226) for relapsed or refractory peripheral T cell lymphoma: an open-label phase 2 study (Gxplore-002). J Hematol Oncol. 2021 Jan 12;14(1):12. doi: 10.1186/s13045-021-01033-1.

  PMID: 33436023 DERIVED

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Yuankai Shi, Doctor

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shawn Yu, Master

CONTACT

86-010-65260820; shawn.yu@genorbio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: April 18, 2018
• Study Start: July 2, 2018
• Primary Completion: August 1, 2021
• Study Completion: December 30, 2022
• Last Updated: March 3, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)