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

NCT03670888 | Terminated Phase 1

• 1 other identifier: JHL-CLIN-1101-02
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

B Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• AUC0-∞

  91 days

• Cmax

  91 days

Study Arms (2)

JHL1101

EXPERIMENTAL

Single dose IV infusion of 375 mg/m2 of JHL1101

Biological: JHL1101

Rituxan

ACTIVE COMPARATOR

Single dose IV infusion of 375 mg/m2 of Rituximab

Biological: Rituximab

Interventions

JHL1101 BIOLOGICAL

100 mg/10 mL solution in a single-use vial

JHL1101

Rituximab BIOLOGICAL

100 mg/10 mL solution in a single-use vial

Rituxan

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• CD20-positive B-cell lymphoma.
• Obtained CR (complete remission) or CRu (uncertain complete remission) after the prior therapy
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• JHL Biotech, Inc.: lead

Study Sites (2)

First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Location

Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Tianjin, Tianjin Municipality, China

Location

MeSH Terms

Conditions

Lymphoma, B-Cell

Interventions

Rituximab

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Lu-Gui Qiu, MD

  Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2018
• First Posted: September 14, 2018
• Study Start: November 16, 2018
• Primary Completion: March 19, 2019
• Study Completion: March 19, 2019
• Last Updated: January 9, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)