ClinicalTrials.gov record NCT07593911

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

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)

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
Age18 years old to 75 years old
SexAll
LocationChina
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This open-label, single-arm study gives MTM-H-001 injection to adults with B-cell-related autoimmune diseases to evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy. It includes a dose-escalation phase followed by dose-expansion cohorts; treatment includes induction and maintenance phases and outcomes are followed for up to 12 months.

What it is studying. The study is testing the safety and tolerability of MTM-H-001, including the rate of dose-limiting toxicities, and aims to characterize how the drug behaves in the body (PK) and its biological effects (PD). It will also collect early measures of disease activity and health-related quality of life to explore preliminary efficacy.

What the researchers hope to learn. Aims to determine the incidence of dose-limiting toxicities (measured within 42 days after first dose), to characterize pharmacokinetics and pharmacodynamics of MTM-H-001, and to collect preliminary data on changes in disease activity, Physician Global Assessment, and health-related quality of life up to 12 months.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • MTM-H-001 Injection

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • 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 criteria

  • 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.

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants receive injections of MTM-H-001 in a dose‑escalation phase (Part A) and, if eligible, a dose‑expansion phase (Part B) with an induction and maintenance schedule. Dose levels and dosing frequency for expansion cohorts are set based on safety, pharmacokinetics (PK), and pharmacodynamics (PD) observed in the escalation part. Study procedures include safety monitoring (watching for dose‑limiting toxicities, especially in the first 42 days), measurement of PK and PD, regular disease activity assessments (for example SLEDAI‑2K where applicable), physician global assessments, and health‑related quality‑of‑life questionnaires over up to 12 months. The registry record does not provide a full visit schedule or further procedural details.

How the study is structured. An open-label (no masking), single-arm interventional study with a sequential dose-escalation part (Part A) and a dose-expansion part (Part B). Participants receive MTM-H-001 injections in an induction phase and then maintenance; doses for expansion cohorts are chosen based on safety, PK, and PD data from escalation. Non-randomized; safety and disease measures are collected and participants are followed over time (up to about 12 months).

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry says recruitment has not started. When is it expected to open, and can I register interest now?
  • The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on IgG4-related disease

Clinical trials32 trials listed for IgG4-related diseaseEvery trial the registry lists for IgG4-related disease, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in IgG4-related disease researchLatest monthly update: September 2026. Includes: Relapse prevention trial. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
June 2026 (estimated)
Primary completion
November 2030 (estimated)
Study completion
June 2031 (estimated)
Target enrollment
75 participants (estimated)
Last updated on registry
May 18, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Beijing GoBroad Hospital
Collaborators
  • MagicTime Medicine

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

open-label
No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.
single-arm
All participants receive the same treatment or follow the same plan. There is no comparison group within the study.
dose-escalation
Groups of participants receive increasing doses of a treatment, one group after another, to find a dose that can be given safely.
PK
How the body absorbs, distributes, breaks down and removes a drug. It is studied by measuring drug levels or related substances at set times after a dose.
Key inclusion criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Informed Consent Form
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Women of childbearing potential
Studies often ask participants who could become pregnant, or could father a child, to use contraception during the study and for a period afterwards, because the effect of the treatment on a pregnancy is unknown.
at screening
The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
Key exclusion criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

← Back to clinical trials