A Study to Evaluate MTM-H-001 Injection in Adult Patients With B-Cell-Related Autoimmune Diseases

Sponsor
Beijing GoBroad Hospital
Study ID
NCT07593911
Status
Not Yet Recruiting

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Conditions

  • IgG4-Related Diseases
  • Lupus Nephritis (LN)
  • Multiple Sclerosis
  • Myasthenia Gravis (MG)
  • Rheumatoid Arthritis (RA)
  • Systemic Lupus Erthematosus (SLE)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • MTM-H-001 Injection — DRUG
    Each participant receives MTM-H-001 Injection

Study Details

This is an investigator-initiated, open-label, single-arm, dose-escalation and dose-expansion study to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of MTM-H-001 in adult participants with B-cell-related autoimmune diseases.

Key Dates

First listed
May 18, 2026
Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Nov 30, 2030
Completion
Jun 30, 2031

Study Design

Enrollment
75 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental group
    Part A: Dose Escalation Part, MTM-H-001 Injection, 5 dose groups are planned; the study treatment period includes an induction phase and a maintenance phase. Part B: Dose Expansion Part, MTM-H-001 Injection, 6 dose cohorts are planned. The dose and frequency for each cohort will be determined based on the safety, PK, and PD data of participants from the dose groups in Part A

Primary Outcome Measure

Incidence of Dose-Limiting Toxicity (DLT) [ Time Frame: 42 days following first dose of MTM-H-001 for each participant ]

Central Contacts

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