New drug MTM-H-001 targets B-Cell autoimmune diseases in early trial
NCT ID NCT07593911
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early study tests a new drug called MTM-H-001 in 75 adults with B-cell-related autoimmune diseases, including lupus, multiple sclerosis, and rheumatoid arthritis. The main goal is to check safety and find the right dose. Participants receive the drug by injection, and researchers will monitor side effects and any changes in disease activity.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- MTM-H-001 injection
- What this could lead to
- If successful, this could point toward a new treatment option for several autoimmune diseases by targeting B-cells.
- What could go wrong
- This is a very early, small study (75 people) with no control group. It primarily checks safety and dosing, so it may not show clear benefit or could have unexpected side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 75 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Key inclusion criteria include: 1. Male or female, aged 18 - 75 years old (inclusive); 2. 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; 3. Confirmed diagnosis of the target autoimmune disease per international classification criteria; 4. Adequate organ function to tolerate treatment; 5. 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: * Key exclusion criteria include: 1. Active, severe, uncontrolled infection; 2. Pregnancy or breastfeeding women; 3. History of malignancy within the protocol-defined period, except adequately treated low-risk cancers; 4. Any condition that, in the investigator's opinion, would compromise safety, compliance, or interpretability of study data.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beijing GoBroad Hospital
Beijing, Beijing Municipality, 102206, China
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