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

NCT ID: NCT03670888

Last Updated: 2020-01-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-16
• Study Completion Date: 2019-03-19

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

JHL1101

Single dose IV infusion of 375 mg/m2 of JHL1101

Group Type: EXPERIMENTAL

JHL1101

Intervention Type: BIOLOGICAL

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

Rituxan

Single dose IV infusion of 375 mg/m2 of Rituximab

Group Type: ACTIVE_COMPARATOR

Rituximab

Intervention Type: BIOLOGICAL

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

Interventions

JHL1101

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

Intervention Type: BIOLOGICAL

Rituximab

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

Intervention Type: BIOLOGICAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

JHL Biotech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lu-Gui Qiu, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

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

Tianjin, Tianjin Municipality, China

Countries

China

Other Identifiers

JHL-CLIN-1101-02

Identifier Type: -

Identifier Source: org_study_id