drugset / Trial / NCT05155839

Safety and Preliminary Efficacy Study of MRG001 in Patients With Non-Hodgkin Lymphoma (NHL)

NCT05155839 ↗

Phase 1 Unknown 108 enrolled Shanghai Miracogen Inc.
NaSingle-groupOpen-labelTreatment

Summary

This study consists of two parts. Phase Ia is a dose escalation study to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of MRG001. Phase Ib is a dose expansion study to assess the preliminary efficacy of MRG001 in patients with CD20-positive relapsed or refractory B-cell NHL at the confirmed RP2D. The safety, tolerability, pharmacokinetic (PK) and immunogenicity of MRG001 will be evaluated in both parts.

Timeline

Start
2019-06-25
Primary completion
2022-10
Completion
2023-10

Drugs

EvaluationDrugModalityDoseRoute
Subject MRG-001 Unknown — Intravenous