Clinical Trial in Chinese Patients of B-cell Non-Hodgkin's Lymphoma(GB226)

Study Description

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Brief 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)

Condition or disease	Intervention/treatment	Phase
B-cell Non-Hodgkin's 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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	53 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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)
Actual Study Start Date :	June 15, 2018
Estimated Primary Completion Date :	September 30, 2018
Estimated Study Completion Date :	December 30, 2020

Arms and Interventions

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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: Genolimzumab Injection

Outcome Measures

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Primary Outcome Measures :

1. ORR [ Time Frame: up to 52 weeks ]
   Objective response rate in accordance with RECIST 1.1

Secondary Outcome Measures :

1. PFS [ Time Frame: up to 52 weeks ]
   Progression-free survival
2. DOR [ Time Frame: up to 52 weeks ]
   duration of response
3. DCR [ Time Frame: up to 52 weeks ]
   disease control rate
4. Assessment of safety parameters [ Time Frame: up to 52 weeks ]
   Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
5. Immunogenicity of Gxplore-003 [ Time Frame: up to 52 weeks ]
   Percentage of patients who develop anti-GB226 antibodies (ADA)

Eligibility Criteria

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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:

• 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):

  1. Recurrence after autologous hematopoietic stem cell transplantation (ASCT), or failure to achieve complete response (CR) or partial response (PR) within 60 days after ASCT. If patients with recurrent or refractory PMBCL after ASCT receive other interventions, the disease shall be recurrent or refractory after the last systemic treatment; or:
  2. Patients not suitable for ASCT must be those with the disease that does not respond to or reoccurs after second-line systemic chemotherapy or above. Local radiotherapy is not considered a separate first-line treatment;
  3. History of treatment with rituximab or incapability of receiving rituximab for any reason；
• Consent to provide archived tumor tissue samples or fresh tissue samples;
• ECOG score: 0-1;
• Expected survival ≥ 3 months;
• 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);
• At least 2 weeks after completion of systemic chemotherapy and targeted therapy; at least 4 weeks after systemic or local palliative radiotherapy;
• At least 2 weeks after discontinuance of systemic corticosteroids (prednisone >10 mg/day or equivalent dose) before enrollment;
• At least 4 weeks after completion of autologous hematopoietic stem cell transplantation before enrollment or contraindication for autologous hematopoietic stem cell transplantation;
• At least 4 weeks after completion of major surgery requiring general anesthesia and recovery from the surgery before enrollment; at least 2 weeks after completion of surgery requiring local anesthesia/epidural anesthesia and recovery from the surgery before enrollment; at least 1 hour after completion of skin biopsy requiring local anesthesia only;
• At least 4 weeks after completion of previous anti-tumor biotherapies (tumor vaccines, cytokines or growth factors for tumor control) before enrollment;
• Blood routine test results: hemoglobin ≥80g/L, neutrophil≥1.0x109/L, platelet count≥80x109/L (no blood transfusion or use of biostimulating factors within 14 days before the test);
• Serum creatinine ≤ 1.5 times upper limit of normal (ULN) or calculated creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula);
• Total bilirubin <1.5 times the ULN 9 [unless Gilbert syndrome is confirmed), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <3 times the ULN (AST and/or ALT ≤5×ULN for patients with liver metastases);
• Thyroid function indicators: thyroid stimulating hormone (TSH), free thyroxine (FT3/FT4) within the normal range;
• Relief of adverse reactions caused by previous treatment to grade 1 and below before enrollment (except hair loss);
• Non-pregnant women identified within 72 hours before administration of drug; male or female subjects during the reproductive period who agree to take effective medically recognized contraceptive measures throughout the study period and within six months of completion of the study;
• Ability to perform regular follow-ups, communicate well with the investigator and complete the study in accordance with the requirements of the study

Exclusion Criteria:

• 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;
• History of active, known autoimmune diseases including but not limited to systemic lupus erythematosus, psoriasis, rheumatoid arthritis, inflammatory bowel disease, Hashimoto's thyroiditis, except Type I Diabetes, hypothyroidism that can be controlled by hormone replacement therapy alone, skin diseases that do not require systemic treatment (such as vitiligo and psoriasis), controlled celiac disease, or diseases that are not expected to recur without external stimuli;
• Previous treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies (or any other antibodies that act on T-cell costimulatory or checkpoint pathways);
• Uncontrolled hypertension (systolic blood pressure ﹥ 140mmHg and/or diastolic blood pressure ﹥ 90mmHg), pulmonary hypertension or unstable angina; myocardial infarction, bypass surgery or stent surgery within 6 months before administration of drug; history of chronic heart failure that meets the criteria for grade 3-4 defined by New York Heart Association (NYHA); clinically significant valvular disease; severe arrhythmia requiring treatment (excluding atrial fibrillation and paroxysmal supraventricular tachycardia), including QTc interval ≥450ms for male subjects and ≥ 470ms for female subjects (calculated by Fridericia formula); left ventricular ejection fraction (LVEF) <50%; cerebral vascular accident (CVA) or transient ischemic attack (TIA) within 6 months before administration of drug;
• Other serious medical conditions, including but not limited to uncontrolled diabetes, active peptic ulcer and active bleeding;
• Active infections requiring systemic treatment;
• Present suffering from active tuberculosis infection;
• Positive human immunodeficiency virus antibody (HIV-Ab), treponema pallidum antibody (TP-Ab) or hepatitis C antibody (HCV-Ab); positive hepatitis B virus surface antigen (HBsAg), and hepatitis B virus DNA copy number > upper limit of normal in the test institution;
• Comorbidities requiring treatment with immunosuppressive drugs, or comorbidities requiring systemic use of corticosteroids at doses with immunosuppressive effects (prednisone >10 mg/day or the same class of drugs at an equivalent dose); in the absence of active autoimmune disease, it is allowed to inhale or topically use steroids and prednisone ＞10mg/day or similar drugs at an equivalent dose.
• Use of any other study drug within 30 days before administration of the study drug or 5 half-lives of another study drug (whichever is longer); or use of test device within 30 days;
• Live vaccines or attenuated vaccines are expected to be administered within 4 weeks before administration of drug, during treatment period or within 5 months after the last dose;
• Uncontrollable or significant pleural effusion or pericardial effusion;
• History of drug addiction or drug abuse upon enquiry;
• Present or past idiopathic pulmonary fibrosis or idiopathic pneumonia;
• Breastfeeding women;
• Known allergy to recombinant humanized PD-1 monoclonal antibody or any of its excipients; known history of allergic disease or severe allergic constitution;
• Poor ability to communicate, understand and cooperate, poor compliance, incapability of complying with the requirements in the protocol

Contacts and Locations

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Contacts

Contact: Huiyang Cheng, Master	86-021-61690700 ext 55522	chenghuiyang@walvax.com
Contact: Jianhua Li, Bachelor	+86-13691192240	lijianhua@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	Study Principal Investigator

More Information

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Responsible Party:	Genor Biopharma Co., Ltd.
ClinicalTrials.gov Identifier:	NCT03639181 History of Changes
Other Study ID Numbers:	Gxplore-003
First Posted:	August 21, 2018
Last Update Posted:	August 21, 2018
Last Verified:	August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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

Keywords provided by Genor Biopharma Co., Ltd.:

B-NHL

Additional relevant MeSH terms:

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