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

NCT03639181 | Unknown Phase 2

• 1 other identifier: Gxplore-003
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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)

Conditions

B-cell Non-Hodgkin's Lymphoma

Keywords

B-NHL

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate, ORR

  To evaluate the efficacy of GB226 as defined by objective response rate, in patients with B-NHL.

  up to 52 weeks

Secondary Outcomes (3)

• Duration of response, DOR

  up to 52 weeks

• Overall survival, OS

  up to 52 weeks

• Progression-free survival, PFS

  up to 52 weeks

Study Arms (1)

GB226 3mg/kg every 2 weeks

EXPERIMENTAL

Geptanolimab Injection, 3mg/kg every 2 weeks

Biological: GB226

Interventions

GB226 BIOLOGICAL

3mg/kg treat every 2 weeks

Also known as: Geptanolimab Injection

GB226 3mg/kg every 2 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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

You may not qualify if:

• 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
• 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;

Sponsors & Collaborators

• Genor Biopharma Co., Ltd.: lead

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

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

Study Officials

• Yuankai Shi, Doctor

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shawn Yu, Master

CONTACT

86-010-65260820; shawn.yu@genorbio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2018
• First Posted: August 21, 2018
• Study Start: October 15, 2018
• Primary Completion: September 1, 2021
• Study Completion: December 30, 2022
• Last Updated: March 3, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)