A Study to Evaluate MTM-H-001 Injection in Adult Patients With B-Cell-Related Autoimmune Diseases (NCT07593911) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Study to Evaluate MTM-H-001 Injection in Adult Patients With B-Cell-Related Autoimmune Diseases
China75 participantsStarted 2026-06
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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 criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial's primary goal is to measure dose-limiting toxicities — meaning researchers are still figuring out what doses are safe — what does that mean for my personal safety if I were to consider enrolling?
2This trial covers several very different B-cell-related autoimmune diseases like lupus, multiple sclerosis, and rheumatoid arthritis all at once — do you think my specific diagnosis would be a good fit for a study designed this broadly?
3The trial isn't recruiting yet, so if I'm dealing with active symptoms right now, would it make more sense to start an established treatment while we wait, rather than holding out for this study to open?
4MTM-H-001 appears to be a new investigational injection with no publicly available safety or efficacy data yet — compared to the approved treatments I could try today, how would you weigh the unknowns of this early-stage study against those existing options?
5If this trial does open and I become eligible, what would the injection schedule and monitoring visits likely look like, and is that kind of commitment realistic given my current health situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Dose-Limiting Toxicity (DLT)
Timeframe: 42 days following first dose of MTM-H-001 for each participant