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drugset / Trial / NCT06725524

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

NCT06725524 ↗

Phase 1 Recruiting 186 enrolled Shanghai JMT-Bio Inc.
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2021-10-12
Primary completion
2025-12-31
Completion
2025-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject JMT601 Unknown 0.3 mg/kg Intravenous
Subject JMT601 Unknown 1 mg/kg Intravenous
Subject JMT601 Unknown 3 mg/kg Intravenous
Subject JMT601 Unknown 6 mg/kg Intravenous
Subject JMT601 Unknown 12 mg/kg Intravenous
Subject JMT601 Unknown 20 mg/kg Intravenous

Indications

B-cell non-Hodgkin lymphoma