A Study to Compare the Bioequivalence and Safety of JHL1101 and Rituximab in CD20 Positive B Cell Lymphoma Patients

Study Overview
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Brief Summary
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This is a multicenter, randomized, double-blind, parallel group study to compare the PK, safety, tolerability, immunogenicity and PD of JHL1101 vs Rituxan in subjects with CD20-positive B cell lymphoma. The study duration is 13 weeks. Approximately 128 eligible subjects will be randomized in a 1:1 ratio to receive either JHL1101 (n=64) or Rituxan (n=64). Each subject will receive one intravenous (IV) infusions of the investigational product (IP) at the dose of 375mg/m2 on Day 1. Assessments of PK, safety, tolerability, immunogenicity, PD, and efficacy will be collected over the following 13-week period.

Official Title
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A Multicenter, Randomized, Double-blind, Parallel-controlled Trial to Compare the Bioequivalence and Safety of the Recombinant Human-Mouse Chimeric Anti-CD20 Monoclonal Antibody Injection (JHL1101) and Rituximab Injection in CD20 Positive B Cell Lymphoma Patients

Conditions
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B Cell Lymphoma

Intervention / Treatment
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* Biological: JHL1101
* Biological: Rituximab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CD20-positive B-cell lymphoma. Obtained CR (complete remission) or CRu (uncertain complete remission) after the prior therapy 18 years to 75 years Signed an informed consent Adequate organ function, including the following Absolute neutrophil count (ANC) ≥ 1,500/uL; platelet count ≥ 75,000/uL; hemoglobin ≥ 8 g/dL Total bilirubin ≤ 1.5 times the upper limit of normal (ULN), aspartate transaminase (AST) and/or alanine aminotransferase (ALT) ≤ 2.5 times ULN Serum creatinine ≤ 1.5 times the ULN Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 Chemotherapy: must not have received within 8 weeks of entry onto this study Radiotherapy: must not have received within 4 weeks of entry onto this study Recovery (to baseline or to Grade 1 or less) from prior treatment-related toxicities except alopecia Aagreement to practice contraception More than 6 months life expectancy. Exclusion Criteria: Received any investigational drug within 28 days prior to study enrollment Received blood transfusion or any therapies with erythropoietin (EPO), granulocyte-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 14 days prior to study enrollment Received previous immunotherapy Received or plan to receive a live vaccine within 28 days of study enrollment Major surgery within 28 days of study enrollment Received systemic steroid therapy with 28 days of study enrollment Received or plan to receive the hematopoietic cell transplant History of gastrointestinal perforation and/or fistula within 6 months prior to study enrollment Known allergic reactions against monoclonal antibody or rituximab. Received rituximab or other anti-CD20 monoclonal antibody Blood concentration of rituximab > 10 ug/mL during screen visit Human immunodeficiency virus (HIV) positive Hepatitis C virus (HCV) antigen and antibody positive Hepatitis B virus surface antigen (HBsAg) positive Body Mass Index (MBI) ≥ 28 kg/m2

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JHL1101<br>Single dose IV infusion of 375 mg/m2 of JHL1101 | Biological: JHL1101<br>* 100 mg/10 mL solution in a single-use vial<br>|
| Active Comparator: Rituxan<br>Single dose IV infusion of 375 mg/m2 of Rituximab | Biological: Rituximab<br>* 100 mg/10 mL solution in a single-use vial<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0 t | Area under the concentration-time curve (AUC) from time 0 (predose) of the first infusion on Day 1 to the last quantifiable concentration | 91 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-∞ | AUC from time 0 of the first infusion on Day 1 extrapolated to infinity | 91 days | 
| Cmax | Maximum concentration after infusion | 91 days |