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

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ClinicalTrials.gov Identifier: NCT03502629
Recruitment Status : Recruiting
First Posted : April 18, 2018
Last Update Posted : August 15, 2018
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


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 97 participants
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 : March 15, 2018
Estimated Primary Completion Date : August 30, 2018
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
GB226 3mg/kg every 2 weeks
Biological: GB226
3mg/kg treat every 2 weeks
Other Name: Recombinant humanized anti-PD-1 monoclonal antibody injection




Primary Outcome Measures :
  1. adverse event [ Time Frame: all adverse events will be recorded from the time the consent form is signed through 30 days following cessation of treatment. ]
    adverse event

  2. Serious Adverse Event [ Time Frame: all serious adverse events will be recorded from the time the consent form is signed through 30 days following cessation of treatment. ]
    Serious Adverse Event



Information from the National Library of Medicine

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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. At least one measurable and evaluable tumor lesion (in accordance with international working group criteria/modified criteria IWC);
  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 times the upper limit of normal (ULN) or creatinine clearance ≥ 50 mL/min (calculated based on Cockcroft-Gault formula), and urinary protein ˂ 2+ or ˂1.0g/L; For patients with baseline urinary protein ≥ 2+ or ≥ 1.0g/L, quantitative test of 24h urinary protein will be performed and will be enrolled only when the result ≤ 1g is obtained.
  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 angioimmunoblastic T-Cell lymphoma (AITL);
  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. Patients who previously had other malignancies (excluding cured cervical carcinoma in situ and skin basal cell carcinoma) are not allowed to participate in the study unless he/she completely relieved at least 2 years before enrollment and requires no other treatment now or during the study period.
  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. Patients with active infection requiring systemic treatment;
  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. Physical examination or laboratory test results showed the patient used prohibited investigational drugs, or had suspected diseases or evidence of symptoms which may put the patient at high risk of getting treatment-related complications.
  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
Contact: Huiyang Cheng, Master 86-021-61690700 ext 55522 chenghuiyang@walvax.com
Contact: Jingjing Cai, Bachelor 86-13810968548 caijingjing@walvax.com

Locations
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
Principal Investigator: Yuankai Shi, Doctor Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Responsible Party: Genor Biopharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT03502629     History of Changes
Other Study ID Numbers: Gxplore-002
First Posted: April 18, 2018    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make individual participant data available.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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