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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Each participant receives MTM-H-001 Injection
Beijing GoBroad Hospital
Beijing, Beijing Municipality, China
Incidence of Dose-Limiting Toxicity (DLT)
Percentage of participants experiencing DLTs
Time frame: 42 days following first dose of MTM-H-001 for each participant
Change from baseline in disease activity
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
Time frame: Throughout the study, up to 12 months for each participant
Change from baseline in Physician Global Assessment (PhGA)
Change of Physician Global Assessment (PhGA) score from baseline
Time frame: Throughout the study, up to 12 months for each participant
Change from baseline in health-related quality of life (HRQoL) score
Change from baseline in health-related quality of life (HRQoL) score
Time frame: Throughout the study, up to 12 months for each participant
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