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

Sponsor
JHL Biotech, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT03670888
Collaborator
(none)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: JHL1101
  • Biological: Rituximab
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
1 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
"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"
Actual Study Start Date :
Nov 16, 2018
Actual Primary Completion Date :
Mar 19, 2019
Actual Study Completion Date :
Mar 19, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: JHL1101

Single dose IV infusion of 375 mg/m2 of JHL1101

Biological: JHL1101
100 mg/10 mL solution in a single-use vial

Active Comparator: Rituxan

Single dose IV infusion of 375 mg/m2 of Rituximab

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

Outcome Measures

Primary Outcome Measures

  1. AUC0~t [91 days]

    Area under the concentration-time curve (AUC) from time 0 (predose) of the first infusion on Day 1 to the last quantifiable concentration

Secondary Outcome Measures

  1. AUC0-∞ [91 days]

    AUC from time 0 of the first infusion on Day 1 extrapolated to infinity

  2. Cmax [91 days]

    Maximum concentration after infusion

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. CD20-positive B-cell lymphoma.

  2. Obtained CR (complete remission) or CRu (uncertain complete remission) after the prior therapy

  3. 18 years to 75 years

  4. Signed an informed consent

  5. 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

  1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

  2. Chemotherapy: must not have received within 8 weeks of entry onto this study

  3. Radiotherapy: must not have received within 4 weeks of entry onto this study

  4. Recovery (to baseline or to Grade 1 or less) from prior treatment-related toxicities except alopecia

  5. Aagreement to practice contraception

  6. More than 6 months life expectancy.

Exclusion Criteria:
  1. Received any investigational drug within 28 days prior to study enrollment

  2. 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

  3. Received previous immunotherapy

  4. Received or plan to receive a live vaccine within 28 days of study enrollment

  5. Major surgery within 28 days of study enrollment

  6. Received systemic steroid therapy with 28 days of study enrollment

  7. Received or plan to receive the hematopoietic cell transplant

  8. History of gastrointestinal perforation and/or fistula within 6 months prior to study enrollment

  9. Known allergic reactions against monoclonal antibody or rituximab.

  10. Received rituximab or other anti-CD20 monoclonal antibody

  11. Blood concentration of rituximab > 10 ug/mL during screen visit

  12. Human immunodeficiency virus (HIV) positive

  13. Hepatitis C virus (HCV) antigen and antibody positive

  14. Hepatitis B virus surface antigen (HBsAg) positive

  15. Body Mass Index (MBI) ≥ 28 kg/m2

Contacts and Locations

Locations

Site City State Country Postal Code
1 First Hospital of Shanxi Medical University Taiyuan Shanxi China
2 Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College Tianjin Tianjin China

Sponsors and Collaborators

  • JHL Biotech, Inc.

Investigators

  • Principal Investigator: Lu-Gui Qiu, MD, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
JHL Biotech, Inc.
ClinicalTrials.gov Identifier:
NCT03670888
Other Study ID Numbers:
  • JHL-CLIN-1101-02
First Posted:
Sep 14, 2018
Last Update Posted:
Jan 9, 2020
Last Verified:
Jan 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 9, 2020