NCT06725524

A Study of JMT601 in Participants With Relapsed or Refractory CD20-positive B-cell Non-Hodgkin Lymphoma

A Phase 1, Open-Label, Multi-center Study Evaluating the Safety and Tolerability of of JMT601 in Participants With Relapsed or Refractory CD20-positive B-cell Non-Hodgkin Lymphoma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 186 (estimated)
• Sponsor: Shanghai JMT-Bio Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1, open-label, multi-center study to evaluate the safety of JMT601 in the treatment of relapsed or refractory CD20-positive B-cell non-Hodgkin lymphoma and to determine the recommended dose for Phase 2 studies (RP2D). Study consists of 2 parts. The first part is a dose-escalation part using a 3+3 design with up to 6 dose(0.3 mg/kg, 1 mg/kg, 3 mg/kg, 6 mg/kg, 12 mg/kg and 20 mg/kg) escalation cohorts at increasing levels. The second part is a dose-expansion part at R2PD dose to assess preliminary efficacy of JMT601.

Conditions

• B-cell Non Hodgkin Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	JMT601	intravenous infusion on day 1 once a week

Timeline

• Start date: 2021-10-12
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2024-12-10
• Last updated: 2024-12-10

Locations

1 site across 1 country: China