Trials / Terminated
TerminatedNCT03670888
A Study to Compare the Bioequivalence and Safety of JHL1101 and Rituximab in CD20 Positive B Cell Lymphoma Patients
"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"
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 1 (actual)
- Sponsor
- JHL Biotech, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | JHL1101 | 100 mg/10 mL solution in a single-use vial |
| BIOLOGICAL | Rituximab | 100 mg/10 mL solution in a single-use vial |
Timeline
- Start date
- 2018-11-16
- Primary completion
- 2019-03-19
- Completion
- 2019-03-19
- First posted
- 2018-09-14
- Last updated
- 2020-01-09
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT03670888. Inclusion in this directory is not an endorsement.