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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03502629
Recruitment Status : Recruiting
First Posted : April 18, 2018
Last Update Posted : December 18, 2019
Sponsor:
Information provided by (Responsible Party):
Genor Biopharma Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Peripheral T Cell Lymphoma Biological: GB226 Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 97 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : July 2, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: GB226 3mg/kg every 2 weeks
Geptanolimab Injection, 3mg/kg every 2 weeks
Biological: GB226
3mg/kg treat every 2 weeks
Other Names:
  • Recombinant humanized anti-PD-1 monoclonal antibody injection
  • Geptanolimab




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Duration of response, DOR [ Time Frame: up to 2 years ]
    To evaluate the duration of response (DOR) of GB226 in Chinese patients with recurrent or refractory PTCL

  2. Overall survival, OS [ Time Frame: up to 2 years ]
    To evaluate the duration from the first administration to death because of any reason in Chinese patients with recurrent or refractory PTCL

  3. Progression-free survival, PFS [ Time Frame: up to 2 years ]
    To evaluate the efficacy of GB226 as defined by progression-free survival, in Chinese patients with recurrent or refractory PTCL

  4. Disease control rate (DCR) [ Time Frame: up to 2 years ]
    To evaluate the efficacy of GB226 as defined by disease control rate, inChinese patients with recurrent or refractory PTCL

  5. Time to response,TTR [ Time Frame: up to 2 years ]
    To evaluate the efficacy of GB226 as defined by time to response in Chinese patients with recurrent or refractory PTCL

  6. Antidrug antibody [ Time Frame: up to 2 years ]
    To evaluate the immunogenicity of GB226 in Chinese patients with recurrent or refractory PTCL



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged 18 years or older, male or female;
  2. Understand study procedures and contents, and voluntarily sign the written informed consent form;
  3. 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.
  4. Agree to provide archived tumor tissue specimens or fresh tissue specimens;
  5. ECOG score of 0-1;
  6. Life expectancy≥3 months;
  7. 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)
  8. Systemic chemotherapy, systemic or local palliative radiotherapy, target therapy has been completed for at least 4 weeks before enrollment.
  9. Systemic corticosteroids (prednisone > 10 mg/day or equivalent dose) has been discontinued at least 2 weeks before enrollment;
  10. Autologous hematopoietic stem cell transplantation (ASCT) has been completed at least 4 weeks before enrollment;
  11. 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.
  12. The previous anti-tumor biotherapy (tumor vaccine aimed at controlling tumor, cytokine or growth factor) has been completed at least 4 weeks before enrollment.
  13. For routine blood tests: hemoglobin ≥ 80 g/L, neutrophil ≥ 1.0 ×109/L, platelet ≥ 80×109/L;
  14. Serum creatinine ≤ 1.5×ULN or creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula);
  15. 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);
  16. Thyroid function indicators: thyroid-stimulating hormone (TSH) and free thyroxine (FT3/FT4) are within the normal range;
  17. The adverse reactions caused by the previous treatment should recover to grade 1 and below (except alopecia);
  18. 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.
  19. Patients can receive follow-up visits as scheduled, well communicate with the investigators and complete the study as required by the study.

Exclusion Criteria:

  1. Diagnosed as vascular immunoblastic t-cell lymphoma (AITL) or adult t-cell lymphoma/leukemia(ATLL);
  2. Patients with active central nervous system (CNS) infiltration and/carcinomatous meningitis; if the central nervous system (CNS) infiltration of patients can be sufficiently treated and patient's central nervous symptoms can recover to clinically stable state for at least 4 weeks before enrollment (residual signs or symptoms associated with CNS treatment are excluded), then such patients can participate in this study.
  3. Previous history of organ transplantation or allogeneic hematopoietic stem cell transplantation
  4. Patients who have active, known or suspected autoimmune diseases;
  5. 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);
  6. Patients with complicated internal diseases, including serious heart disease, cerebrovascular disease, uncontrolled diabetes mellitus or hypertension, active gastrointestinal ulceration, active bleeding etc.;
  7. Uncontrolled hypertension (systolic blood pressure > 140mmHg and/or diastolic blood pressure > 90mmHg) or pulmonary hypertensionOr unstable angina; Had myocardial infarction or bypass or stent surgery within 6 months before the drug administration; The heart of New YorkNYHA standard grade 3-4 history of chronic heart failure; Valvular disease with clinical significance; Need to treatSevere arrhythmias treated included QTc interval ≥450ms for male and ≥470ms for female (Fridericia formula)Computing); Left ventricular ejection fraction (LVEF) < 50%; Cerebrovascular accident (CVA) within 6 months before administrationOr transient ischemic attack (TIA);
  8. Patients with active pulmonary tuberculosis; patients who previously had active pulmonary tuberculosis;
  9. 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);
  10. Patients with complications requiring treatment with immunosuppressive drugs or systemic or local corticosteroids at the immunosuppressive doses;
  11. Patients who had used other investigations drugs within 30 days before the use of this investigational drug or within 5 half-lives of the previous investigational drugs (whichever is longer) or had used investigational medical device within 30 days;
  12. Patients receiving any anti-infection vaccine (e.g. influenza vaccine, varicella vaccine etc.) within 4 weeks before enrollment;
  13. Patients with symptomatic pleural, peritoneal and pericardial effusion;
  14. Patients with drug abuse history or alcohol addiction history;
  15. Patients with current or previous interstitial lung diseases;
  16. Lactating women;
  17. Patients who had been previously treated with any other investigational drugs or participated in another clinical study within 30 days before enrollment;
  18. Patients who are allergic to recombinant humanized antibody or any of its excipients;
  19. Known allergies to recombinant humanized monoclonal antibody or any of its excipient components; A known history of severe allergic disease;
  20. Patients who have insufficient communication, understanding and cooperation; or patients who have poor compliance and cannot guarantee to strictly follow the study protocol;
  21. Subjects who are considered unsuitable for participating in this study for various reasons at the discretion of the investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03502629


Contacts
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Contact: Shawn Yu, Master 86-010-65260820 shawn.yu@genorbio.com

Locations
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China, Beijing
Cancer Hospital Chinese Academy of Medical Sciences Recruiting
Beijing, Beijing, China, 100021
Contact: Yuankai Shi, Doctor         
Principal Investigator: Yuankai Shi, Doctor         
Sponsors and Collaborators
Genor Biopharma Co., Ltd.
Investigators
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Principal Investigator: Yuankai Shi, Doctor Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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Responsible Party: Genor Biopharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT03502629    
Other Study ID Numbers: Gxplore-002
First Posted: April 18, 2018    Key Record Dates
Last Update Posted: December 18, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make individual participant data available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs