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

NCT06725524 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2024-12-10

No results posted yet for this study

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

BIOLOGICAL

JMT601

intravenous infusion on day 1 once a week

Sponsors & Collaborators

  • Shanghai JMT-Bio Inc.

    lead INDUSTRY

Principal Investigators

  • Weili Zhao · Ruijin Hospital Clinical, Shanghai Jiao Tong University, School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06725524 on ClinicalTrials.gov