B-cell Non-Hodgkin's LymphomaPhase 2NCT03639181
Clinical Trial in Chinese Patients of B-cell Non-Hodgkin's Lymphoma(GB226)
A Phase 2 study testing GB226 in people with B-cell Non-Hodgkin's Lymphoma, run by Genor Biopharma Co., Ltd. at 1 site in China.
Trial summary
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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-cell Non-Hodgkin's 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
- 53 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 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
- Age ≥18 years old, male or female;
- Understanding of procedures and contents of the study, and voluntary signing of written informed consent form;
- Histopathologically confirmed Primary Mediastinal B-cell Lymphoma (PMBCL):
- Consent to provide archived tumor tissue samples or fresh tissue samples;
- ECOG score: 0-1;
- Expected survival ≥ 3 months;
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- Computed tomography scans performed within 28 days prior to study enrollment should show at least one tumor lesion that can be clearly measured in two perpendicular directions. The longest diameter of intranodal lesion is >1.5 cm, and the longest diameter of extranodal lesion is >1.0 cm (according to the 2014 lugano standard);
- Blood routine requirements: hemoglobin ≥80 g/L, neutrophil ≥1.0 × 109 /L, platelet ≥75× 109 /L (before test)No blood transfusion or biostimulant for 14 days);
- Serum creatinine ≤1.5 ULN or creatinine clearance ≥50 mL/min (Cockcroft-Gault formula)
- Total bilirubin ≤1.5 ULN (Gilbert syndrome allows ≤5 ULN), aspartic acid transaminase (AST)ALT≤ 2.5 ULN (AST and/or ALT≤5×ULN is allowed in patients with liver metastasis)
- Thyroid function indexes: thyrotropic hormone (TSH) and free thyroxine (FT3/FT4) were in the normal range.If TSH and FT3 are not in the normal range, FT4 can be included.
- Women should be confirmed not pregnant within 7 days before administration; both males and females agree to do effective contraceptive measures during the trial and 6 months after completion;
- Patients were able to visit according to the schedule and communicate well with the investigator and complete the study in accordance with the protocol
Who cannot join
- Patients with history of other malignant tumors (except cured cervical cancer in situ, basal cell carcinoma or squamous epithelial cancer) may not participate in the study unless complete response lasts for at least 2 years prior to enrollment, and it is estimated that no other treatment will be required throughout the study;
- Definite central nervous system (CNS) infiltration of lymphoma, including brain parenchyma, meningeal invasion or spinal cord compression;
- Systemic chemotherapy and targeted therapy were carried out within 2 weeks before the experimental medication, and radical/generalized radiotherapy was carried out within 4 weeks.Anti-tumor biotherapy (tumor vaccine, cytokines or growth factors for the purpose of tumor control); In 1 weeksLocal palliative radiotherapy;
- A systemic corticosteroid (prednisone >10 mg/ d or equivalent) was administered within 2 weeks before administration;
- Autologous hematopoietic stem cell transplantation was performed within 2 months and allogeneic hematopoietic stem cell transplantation was performed within 5 years plant;
- Major surgery under general anesthesia was performed within 4 weeks before the trial. Local anesthesia/epidural anesthesia within 2 weeks surgery
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- Active, known history of autoimmune diseases, including but not limited to systemic lupus erythematosus, psoriasis, and type iiRheumatoid arthritis, inflammatory bowel disease, hashimoto's thyroiditis, etc., except: type 1 diabetes, only through hormonesHypothyroidism that can be controlled with alternative therapies, skin diseases that do not require systemic treatment (e.g. vitiligo, psoriasis),Controlled celiac disease or disease in which no recurrence is expected without an external stimulus
- Uncontrolled hypertension (systolic blood pressure > 140mmHg and/or diastolic blood pressure > 90mmHg) or pulmonary hypertension orUnstable angina pectoris; Had myocardial infarction or bypass or stent surgery within 6 months before the drug administration; Meet in New YorkA history of chronic heart failure at NYHA level 3-4; Valvular disease with clinical significance; Need to beTreated severe arrhythmia (except atrial fibrillation and paroxysmal supraventricular tachycardia), including QTc interphase male ≥450ms, female ≥470ms (calculated by Fridericia formula); Left ventricular ejection fraction (LVEF) < 50%;Cerebrovascular accident (CVA) or transient ischemic attack (TIA) etc. occurred within 6 months before the administration;
- Other serious medical conditions, including but not limited to: uncontrolled diabetes, active digestive tract ulcers,Active hemorrhage, etc;
- Active infectious persons requiring systemic treatment;
- Previous or current active TB infectious patient;
- Human immunodeficiency virus antibody (hiv-ab) and treponema pallidum antibody (tp-ab) were positive. Hepatitis c antibody (HCV-Ab) positive, and the upper limit of normal value of HCV RNA quantitative > detection unit; Hepatitis b virus surface antigen (HBsAg)Positive, and HBV DNA quantitative > detection unit normal limit;
- Complications that require systemic immunosuppressive drug therapy or that require an immunosuppressive dose (prednisone)> 10 mg/ day or equivalent dose of similar drugs) systemic treatment complications; In the absence of active autoimmune diseaseIn this case, inhaled or locally administered steroids and > 10mg/ d prednisone or equivalent dose are allowed;
- Adverse reactions from previous treatment did not return to level 1 or below before medication (CTCAE5.0) (alopecia and chemotherapyDrug induced grade 2 neurotoxicity excepted);
- Uncontrolled or symptomatic pleural or pericardial effusion;
- Previous use of anti-pd-1 antibodies, anti-pd-l1 antibodies, anti-pd-l2 antibodies or anti-ctla-4 antibodies (orAny other antibodies that act on T cell synergistic stimulation or checkpoint pathways);
- Other experimental drugs or experimental instruments were used within 30 days before administration;
- Live or attenuated vaccines were administered within 4 weeks of trial administration;
- A history of drug abuse or drug abuse was enquired;
- History of interstitial lung disease;
- Lactating women who do not want to stop breastfeeding;
- Known allergy to recombinant humanized pd-1 monoclonal antibody or any of its excipients; A known history of allergic disease or severe allergies;
- Patients with insufficient communication, understanding and cooperation, or poor compliance, can not be guaranteed to follow the program requirements;
- The researchers concluded that participants in this clinical trial were not suitable for a variety of other reasons.
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 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)
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)
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
- B-cell Non-Hodgkin's Lymphoma
- Being tested
- GB226
- Keywords
- B-NHL
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GB226Biological
Also called Geptanolimab Injection
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 patients with B-NHL.
Measured: up to 52 weeks
Secondary outcomes (3)
Duration of response, DOR
To evaluate the duration of response (DOR) of GB242 in patients with B-NHL.
Measured: up to 52 weeks
Overall survival, OS
To evaluate the duration from the first administration to death because of any reason in patients with B-NHL.
Measured: up to 52 weeks
Progression-free survival, PFS
To evaluate the efficacy of GB226 as defined by progression-free survival, in patients with B-NHL.
Measured: up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start15 Oct 2018
- Primary completionSep 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.
- Other trials for B-cell Non-Hodgkin's 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
- 53 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
- NCT03639181
- Sponsor's protocol ID
- Gxplore-003
- Status last verified
- Mar 2021
- First submitted
- 13 Aug 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
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 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)
- ClinicalTrials.gov ID
- NCT03639181
- Acronym / sponsor ID
- Gxplore-003
- Conditions
- B-cell Non-Hodgkin's Lymphoma
- Keywords
- B-NHL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Genor Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 21 Aug 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.
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)
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 (13 listed)
- Age ≥18 years old, male or female;
- Understanding of procedures and contents of the study, and voluntary signing of written informed consent form;
- Histopathologically confirmed Primary Mediastinal B-cell Lymphoma (PMBCL):
- Consent to provide archived tumor tissue samples or fresh tissue samples;
- ECOG score: 0-1;
Key exclusion criteria (24 listed)
- Patients with history of other malignant tumors (except cured cervical cancer in situ, basal cell carcinoma or squamous epithelial cancer) may not participate in the study unless complete response lasts for at least 2 years prior to enrollment, and it is estimated that no other treatment will be required throughout the study;
- Definite central nervous system (CNS) infiltration of lymphoma, including brain parenchyma, meningeal invasion or spinal cord compression;
- Systemic chemotherapy and targeted therapy were carried out within 2 weeks before the experimental medication, and radical/generalized radiotherapy was carried out within 4 weeks.Anti-tumor biotherapy (tumor vaccine, cytokines or growth factors for the purpose of tumor control); In 1 weeksLocal palliative radiotherapy;
- A systemic corticosteroid (prednisone >10 mg/ d or equivalent) was administered within 2 weeks before administration;
- Autologous hematopoietic stem cell transplantation was performed within 2 months and allogeneic hematopoietic stem cell transplantation was performed within 5 years plant;
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: Geptanolimab Injection3mg/kg treat every 2 weeks | Biological | GB226 3mg/kg every 2 weeks |
Primary outcome
Objective Response Rate, ORR
Time frame: up to 52 weeks
To evaluate the efficacy of GB226 as defined by objective response rate, in patients with B-NHL.
3 secondary outcomes
Duration of response, DOR
Time frame: up to 52 weeks
Overall survival, OS
Time frame: up to 52 weeks
Progression-free survival, PFS
Time frame: up to 52 weeks
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.
- Individual participant dataSharing planned: No
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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 B-cell Non-Hodgkin's 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 13 inclusion and 24 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 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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; AzTrials last refreshed its copy on 8 Nov 2026.