MTM-H-001 injection for adults with autoimmune diseases linked to B cells
Tests MTM-H-001 injection in adults with lupus, multiple sclerosis, and related autoimmune diseases.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate MTM-H-001 Injection in Adult Patients With B-Cell-Related Autoimmune Diseases
Key facts
- Where
- Beijing, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07593911, who can take part
Where in China
- Beijing GoBroad HospitalBeijing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Beijing GoBroad Hospital
- Trial code
- NCT07593911
- Record updated
- 18 May 2026
- Original description
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.Read full original descriptionShow less
An Open-Label, Single-Arm, Dose-Escalation and Expansion Basket Study Evaluating the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and Preliminary Efficacy of MTM-H-001 in Patients With B-Cell-Related Autoimmune Diseases (ArchAid-002)
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.
Inclusion: 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.
Exclusion: 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.