A Study to Learn More About the Effects and Safety of JMT601 in Adults With Primary Membranous Nephropathy

Sponsor
Shanghai JMT-Bio Inc.
Study ID
NCT07029139
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Primary Membranous Nephropathy

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • JMT601 Injection — DRUG
    In accordance with the protocol
  • Rituximab — DRUG
    In accordance with the protocol
  • Cyclosporin Capsules — DRUG
    In accordance with the protocol

Study Details

This study is a multicenter, randomized, controlled, open-label, Phase Ⅱ clinical study to evaluate the efficacy, safety, Pharmacokinetics characteristics, Pharmacodynamics effects, and immunogenicity of JMT601 in participants with primary membranous nephropathy. The study has two parts. Part one is dose escalation part, and Part two is dose expansion part.

Key Dates

Start date
Jun 30, 2025
Status verified
Jun 2025
Primary completion
Apr 1, 2027
Completion
Mar 1, 2029

Study Design

Enrollment
156 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: JMT601 (Part 1)
    JMT601
  • Active Comparator: Rituximab (Part 1)
    Rituximab
  • Experimental: JMT601 (Part 2)
    JMT601
  • Active Comparator: Cyclosporin Capsules (part 2)
    Cyclosporin Capsules

Primary Outcome Measure

Incidence of adverse events in Part 1 [ Time Frame: Up to 24 weeks ]

Central Contacts

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