A Study to Evaluate MTM-H-001 Injection in Adult Patients With B-Cell-
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)
What it found
No result yet.
What was tested
Treatment tested
- MTM-H-001 Injection
What it measured
Main measures
Incidence of Dose-Limiting Toxicity (DLT)
42 days following first dose of MTM-H-001 for each participant
Safety
Other measures (3)
Change from baseline in disease activity
Throughout the study, up to 12 months for each participant
Change from baseline in Physician Global Assessment (PhGA)
Throughout the study, up to 12 months for each participant
Change from baseline in health-related quality of life (HRQoL) score
Throughout the study, up to 12 months for each participant
Quality of life (reported by participants)
Who could take part
MS (type not specified) · 18 to 75
Show the full criteria
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.
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
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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History
Started
Jun 2026
Main results due
Nov 2030
Finished
Jun 2031