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NCT Number: NCT07593911

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

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.

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Key information

Conditions

Systemic Lupus Erthematosus (SLE) Arthritis Arthritis, Rheumatoid Autoimmune Diseases Autoimmune Diseases of the Nervous System Connective Tissue Diseases Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis IgG4-Related Diseases Immune System Diseases Immunoglobulin G4-Related Disease Joint Diseases Kidney Diseases Lupus Erythematosus, Systemic Lupus Nephritis Lupus Nephritis (LN) Male Urogenital Diseases Multiple Sclerosis Musculoskeletal Diseases Myasthenia Gravis Myasthenia Gravis (MG) Neoplasms Neoplasms by Site Nephritis Nervous System Diseases Nervous System Neoplasms Neurodegenerative Diseases Neuromuscular Diseases Neuromuscular Junction Diseases Paraneoplastic Syndromes Paraneoplastic Syndromes, Nervous System Rheumatic Diseases Rheumatoid Arthritis (RA) Skin and Connective Tissue Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing GoBroad Hospital

Beijing, Beijing Municipality, 102206, China

Location contact

Jing Pan, Ph.D

CONTACT

[email protected]

+86-010-50847588 ext. 869

Jing Pan, Ph.D

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MTM-H-001 Injection

Drug

Each participant receives MTM-H-001 Injection

Primary outcomes

  1. Incidence of Dose-Limiting Toxicity (DLT)

    Time frame: 42 days following first dose of MTM-H-001 for each participant

    Percentage of participants experiencing DLTs

Secondary outcomes

  1. Change from baseline in disease activity

    Time frame: Throughout the study, up to 12 months for each participant

    Change from baseline in autoimmune disease activity, e.g. Change from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score for SLE

  2. Change from baseline in Physician Global Assessment (PhGA)

    Time frame: Throughout the study, up to 12 months for each participant

    Change of Physician Global Assessment (PhGA) score from baseline

  3. Change from baseline in health-related quality of life (HRQoL) score

    Time frame: Throughout the study, up to 12 months for each participant

    Change from baseline in health-related quality of life (HRQoL) score

Study contacts

Contact information is provided by the study sponsor or research team.

Jing Pan, Ph.D

CONTACT

[email protected]

+86-010-50847588 ext. 869

Yusha Huang

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Beijing GoBroad Hospital

Other

Collaborators

  • MagicTime Medicine

Registry information

Official study title

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)

Acronym: ArchAid-002

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
May 18, 2026
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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