IgG4-Related Diseases, Lupus Nephritis (LN), Multiple Sclerosis, Myasthenia Gravis (MG), Rheumatoid Arthritis (RA), Systemic Lupus Erthematosus (SLE)
Conditions
Brief summary
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
Each participant receives MTM-H-001 Injection
Sponsors
Beijing GoBroad Hospital
MagicTime Medicine
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Dose-Limiting Toxicity (DLT) | 42 days following first dose of MTM-H-001 for each participant | Percentage of participants experiencing DLTs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in disease activity | 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 |
| Change from baseline in Physician Global Assessment (PhGA) | Throughout the study, up to 12 months for each participant | Change of Physician Global Assessment (PhGA) score from baseline |
| Change from baseline in health-related quality of life (HRQoL) score | Throughout the study, up to 12 months for each participant | Change from baseline in health-related quality of life (HRQoL) score |
Countries
China
Contacts
CONTACTJing Pan, Ph.D
CONTACTYusha Huang
PRINCIPAL_INVESTIGATORJing Pan, Ph.D
Beijing GoBroad Hospital
Outcome results
None listed