NCT05155839

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

An Open-label, Multicenter, First-in-human, Phase I Dose-escalation and Expansion Clinical Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of MRG001 in Patients With CD20-positive Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (NHL)

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Shanghai Miracogen Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (NHL)

Interventions

Type	Name	Description
DRUG	MRG001	Administrated intravenously

Timeline

• Start date: 2019-06-25
• Primary completion: 2022-10-01
• Completion: 2023-10-01
• First posted: 2021-12-14
• Last updated: 2022-02-22

Locations

12 sites across 1 country: China