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
Not yet recruiting
Phase of Trial: Phase I
Latest Information Update: 20 Sep 2018
At a glance
- Drugs Rituximab (Primary)
- Indications B cell lymphoma
- Focus Pharmacokinetics
- Sponsors JHL Biotech
- 12 Sep 2018 Status changed from planning to not yet recruiting.
- 05 Jul 2018 According to JHL Biotech media release, the Center for Drug Evaluation (CDE), State Drug Administration of China (SDA) has approved the Phase I Clinical Trial Application for JHL1101 to treat non-Hodgkin lymphoma. JHL will begin the clinical trial in the following months.
- 17 Jul 2017 According to a JHL Biotech media release, Clinical Trial Application (CTA) for use of JHL1101 in phase I clinical trial in Non-Hodgkins Lymphoma patients is under review by the China Food and Drug Administration (CFDA) Center for Drug Evaluation (CDE).