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.
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;
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.
Sequential
MTM-H-001 Injection
DrugEach participant receives MTM-H-001 Injection
Incidence of Dose-Limiting Toxicity (DLT)
Percentage of participants experiencing DLTs
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
Change from baseline in Physician Global Assessment (PhGA)
Change of Physician Global Assessment (PhGA) score from baseline
Change from baseline in health-related quality of life (HRQoL) score
Change from baseline in health-related quality of life (HRQoL) score
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Beijing GoBroad Hospital
Lead sponsor
MagicTime Medicine
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
