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NCT07593911Not yet recruiting

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

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)

Source: ClinicalTrials.gov · Last updated 18 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
75 (estimated)
First submitted
12 May 2026
Start date
Jun 2026
Primary completion date
Nov 2030
Lead sponsor
Beijing GoBroad Hospital
NCT number
NCT07593911

What you commit to

  • Study type: Interventional
  • Planned participants: 75
  • From Jun 2026 to the primary completion date, Nov 2030
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Beijing GoBroad Hospital
Coordinator of this site? Confirm its status		BeijingChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.