CD20-positive Non-Hodgkin Lymphoma Clinical Trial
Official title:
A Phase I/II Study Evaluating the Safety, Efficacy, and Pharmacokinetics of EX103 in Subjects With Relapsed/Refractory CD20-Positive Non-Hodgkin Lymphoma
This is a multicenter, single-arm, open, dose-escalation Phase I/II clinical trial, consisting of a dose-escalation phase (accelerated titration phase, 3+3 design) and a dose expansion phase.
Based on the safety, tolerability, PK results, and antitumor activity of EX103 in patients with relapsed or refractory CD20-positive non-Hodgkin lymphoma, this study will determine dose-limiting toxicity (DLT) and determine the maximum tolerated dose (MTD) or optimal biological dose (OBD) to provide a basis for the recommended Phase 2 dose (RP2D). The dose expansion phase will further evaluate the safety, tolerability, PK, PD profile, initial antitumor effect, and immunogenicity of several extended cohorts. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT03578198 -
Rituximab Plus MG4101 Indolent CD20-positive Non-Hodgkin Lymphoma (NHL)
|
Phase 2 |