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

Phase 1

Terminated

• Conditions: B Cell Lymphoma
• Interventions: Biological: Rituximab; Biological: JHL1101

• Registration Number: NCT03670888
• Lead Sponsor: JHL Biotech, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-12
• Study First Submitted QC: 2018-09-12
• Study First Posted: 2018-09-14
• Study Start: 2018-11-16
• Primary Completion: 2019-03-19
• Study Completion: 2019-03-19
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-06
• Last Update Posted: 2020-01-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rituxan	Rituximab	Single dose IV infusion of 375 mg/m2 of Rituximab
JHL1101	JHL1101	Single dose IV infusion of 375 mg/m2 of JHL1101

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Cmax	91 days	Maximum concentration after infusion
AUC0-∞	91 days	AUC from time 0 of the first infusion on Day 1 extrapolated to infinity

Trial Locations

Locations (2)

Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College; 🇨🇳 Tianjin, Tianjin, China

First Hospital of Shanxi Medical University; 🇨🇳 Taiyuan, Shanxi, China