A Study to Evaluate MTM-H-001 Injection in Adult Patients With B-Cell-Related Autoimmune Diseases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MTM-H-001 Injection.
- Who it may be relevant to
- Registry conditions: Systemic Lupus Erthematosus (SLE), Lupus Nephritis (LN), Multiple Sclerosis, Myasthenia Gravis (MG). Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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)
Overview
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
- Drug MTM-H-001 Injection
Each participant receives MTM-H-001 Injection
Primary outcome measures
- Incidence of Dose-Limiting Toxicity (DLT) [Time frame: 42 days following first dose of MTM-H-001 for each participant]
Secondary outcome measures (3)
- Change from baseline in disease activity [Time frame: Throughout the study, up to 12 months for each participant]
- Change from baseline in Physician Global Assessment (PhGA) [Time frame: Throughout the study, up to 12 months for each participant]
- Change from baseline in health-related quality of life (HRQoL) score [Time frame: Throughout the study, up to 12 months for each participant]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing GoBroad Hospital — Beijing
Identifiers
NCT: NCT07593911 · MTM-H-001-003