NCT03980379

Pharmacokinetics, Efficacy and Safety of the 304 Injection

A Study of Pharmacokinetics, Efficacy, and Safety of 304 Injection Compared With Rituximab in B Cell Non-Hodgkin's Lymphoma

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the pharmacokinetic of the experimental drug 304 injection compared with rituximab injection in patients with CD20 positive B-cell non-Hodgkin lymphoma who had previously achieved CR/CRu status but had not deteriorated or relapsed. While to assess the safety and efficacy of the experimental drug 304 injection compared with rituximab injection.

Detailed description

This is a multi-center, randomized, double-blind, parallel controlled, single-dose study to evaluate the pharmacokinetic, safety and efficacy of 304 injection compared with rituximab injection. To avoid the impact of tumor burden on pharmacokinetics, this study will be conducted in CD20 positive B-cell non-Hodgkin lymphoma patients who have achieved CR/CRu status and have not yet deteriorated or relapsed. All patients will be randomly averagely entered into the experimental group and the control group.

Conditions

• CD20 Positive B Cell NHL

Interventions

Type	Name	Description
DRUG	304 injection	Monoclonal antibodies, 100mg/10ml per injection
DRUG	rituximab injection	100mg/10ml per injection ，manufactured by Roche

Timeline

• Start date: 2018-12-18
• Primary completion: 2019-06-30
• Completion: 2019-10-31
• First posted: 2019-06-10
• Last updated: 2019-06-10

Locations

10 sites across 1 country: China