A Study to Evaluate MTM-H-001 Injection in Adult Patients With B-Cell-Related Autoimmune Diseases
Starting soon · Not applicable
Conditions studied: Systemic Lupus Erthematosus (SLE), Lupus Nephritis (LN), Multiple Sclerosis, Myasthenia Gravis (MG), IgG4-Related Diseases, Rheumatoid Arthritis (RA)
In brief
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 facts
- Study ID
- NCT07593911
- Run by
- Beijing GoBroad Hospital
- People needed
- 75
- Starts
- 2026-06-01
- Expected to finish
- 2031-06-01
- Last updated by the study team
- 2026-05-18
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Key inclusion criteria include：
- Male or female, aged 18 - 75 years old (inclusive);
- The participant or his/her legally acceptable representative gives consent to this clinical study participation and signs an Informed Consent Form (ICF) indicating their understanding of the objectives and procedures of the clinical study and willingness to participate in the study;
- Confirmed diagnosis of the target autoimmune disease per international classification criteria;
- Adequate organ function to tolerate treatment;
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and agree to use at least one effective contraceptive method throughout the study and within 6 months after the last treatment cycle.
You may not qualify if…
- Key exclusion criteria include:
- Active, severe, uncontrolled infection;
- Pregnancy or breastfeeding women;
- History of malignancy within the protocol-defined period, except adequately treated low-risk cancers;
- Any condition that, in the investigator's opinion, would compromise safety, compliance, or interpretability of study data.
Where it is running
- Beijing GoBroad Hospital — Beijing, Beijing Municipality, China
Full record on ClinicalTrials.gov
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