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

• ClinicalTrials.gov Identifier: NCT03670888
• Recruitment Status: Terminated
• First Posted: September 14, 2018
• Last Update Posted: January 9, 2020
• Sponsor: JHL Biotech, Inc.
• Information provided by (Responsible Party): JHL Biotech, Inc.

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
B Cell Lymphoma	Biological: JHL1101; Biological: Rituximab	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• 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: November 16, 2018
• Actual Primary Completion Date: March 19, 2019
• Actual Study Completion Date: March 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 [ Time Frame: 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-∞ [ Time Frame: 91 days ]
   AUC from time 0 of the first infusion on Day 1 extrapolated to infinity
2. Cmax [ Time Frame: 91 days ]
   Maximum concentration after infusion

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
7. Chemotherapy: must not have received within 8 weeks of entry onto this study
8. Radiotherapy: must not have received within 4 weeks of entry onto this study
9. Recovery (to baseline or to Grade 1 or less) from prior treatment-related toxicities except alopecia
10. Aagreement to practice contraception
11. 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

China, Shanxi

First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

China, Tianjin

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

More Information

• Responsible Party: JHL Biotech, Inc.
• ClinicalTrials.gov Identifier: NCT03670888
• Other Study ID Numbers: JHL-CLIN-1101-02
• First Posted: September 14, 2018
• Last Update Posted: January 9, 2020
• Last Verified: January 2020

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
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Lymphoma; Lymphoma, B-Cell; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin; Rituximab; Antineoplastic Agents, Immunological; Antineoplastic Agents; Immunologic Factors; Physiological Effects of Drugs; Antirheumatic Agents