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

B Cell Lymphoma Clinical Trial

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"

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03670888
• Other study ID #: JHL-CLIN-1101-02
• Status: Terminated
• Phase: Phase 1
• Start date: November 16, 2018
• Est. completion date: March 19, 2019

Study information

• Verified date: January 2020
• Source: JHL Biotech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: March 19, 2019
• Est. primary completion date: March 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• B Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell

Intervention

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

Locations

Country	Name	City	State
China	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

Sponsors (1)

Lead Sponsor	Collaborator
JHL Biotech, Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	AUC0-8	AUC from time 0 of the first infusion on Day 1 extrapolated to infinity	91 days
Secondary	Cmax	Maximum concentration after infusion	91 days