Peripheral T Cell LymphomaPhase 2NCT03502629
Clinical Trial in Chinese Patients of Relapsed and Refractory Peripheral T Cell Lymphoma (GB226)
A Phase 2 study testing GB226 in people with Peripheral T Cell Lymphoma, run by Genor Biopharma Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral T Cell Lymphoma
- What is being tested?
- GB226
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteChina
- Study dates
- 2 Jul 2018to 30 Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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);
- Thyroid function indicators: thyroid-stimulating hormone (TSH) and free thyroxine (FT3/FT4) are within the normal range;
- The adverse reactions caused by the previous treatment should recover to grade 1 and below (except alopecia);
- Females of child-bearing potential have negative serum pregnancy test; males or females agree to adopt medically confirmed contraceptive measures during the entire study and within 6 months after the end of this study.
- Patients can receive follow-up visits as scheduled, well communicate with the investigators and complete the study as required by the study.
Who cannot join
- 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.;
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- 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;
- Lactating women;
- Patients who had been previously treated with any other investigational drugs or participated in another clinical study within 30 days before enrollment;
- Patients who are allergic to recombinant humanized antibody or any of its excipients;
- Known allergies to recombinant humanized monoclonal antibody or any of its excipient components; A known history of severe allergic disease;
- Patients who have insufficient communication, understanding and cooperation; or patients who have poor compliance and cannot guarantee to strictly follow the study protocol;
- Subjects who are considered unsuitable for participating in this study for various reasons at the discretion of the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Yuankai Shi, Doctor
Yuankai Shi, Doctor
About this study
Official title: 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)
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.
Read the 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
- Being tested
- GB226
- Medical subject headings
- Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GB226Biological
Also called Recombinant humanized anti-PD-1 monoclonal antibody injection, Geptanolimab
3mg/kg treat every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| GB226 3mg/kg every 2 weeks | Experimental | Geptanolimab Injection, 3mg/kg every 2 weeks Receives: Biological: GB226 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate, ORR
To evaluate the efficacy of GB226 as defined by objective response rate in Chinese patients with recurrent or refractory PTCL
Measured: up to 2 years
Secondary outcomes (7)
Duration of response, DOR
To evaluate the duration of response (DOR) of GB226 in Chinese patients with recurrent or refractory PTCL
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: up to 2 years
Antidrug antibody
To evaluate the immunogenicity of GB226 in Chinese patients with recurrent or refractory PTCL
Measured: up to 2 years
Adverse Effect (AE)
To evaluate the adverse effect of GB226 in Chinese patients with recurrent or refractory PTCL
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start2 Jul 2018
- Primary completionAug 2021 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peripheral T Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genor Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuankai Shi, Doctor, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03502629
- Sponsor's protocol ID
- Gxplore-002
- Status last verified
- Mar 2021
- First submitted
- 11 Apr 2018
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make individual participant data available.
Publications
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.
PubMed 40199606Shi 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.
PubMed 33436023
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT03502629
- Acronym / sponsor ID
- Gxplore-002
- Conditions
- Peripheral T Cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Genor Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Jul 2018 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 18 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GB226 3mg/kg every 2 weeks | Experimental | Biological: GB226Geptanolimab Injection, 3mg/kg every 2 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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;
Key exclusion criteria (21 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GB226Also: Recombinant humanized anti-PD-1 monoclonal antibody injection, Geptanolimab3mg/kg treat every 2 weeks | Biological | GB226 3mg/kg every 2 weeks |
Primary outcome
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
7 secondary outcomes
Duration of response, DOR
Time frame: up to 2 years
Overall survival, OS
Time frame: up to 2 years
Progression-free survival, PFS
Time frame: up to 2 years
Disease control rate (DCR)
Time frame: up to 2 years
Time to response,TTR
Time frame: up to 2 years
Antidrug antibody
Time frame: up to 2 years
Adverse Effect (AE)
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Derived from this study: PubMed 40199606Lou 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.
- Derived from this study: PubMed 33436023Shi 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.
- Individual participant dataSharing planned: No. There is not a plan to make individual participant data available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuankai Shi, Doctor principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GB226 in people with Peripheral T Cell Lymphoma, run by Genor Biopharma Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shawn Yu, Master (86-010-65260820, shawn.yu@genorbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate, ORR (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03502629, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.