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| Name | Class |
|---|---|
| MagicTime Medicine | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Part A: Dose Escalation Part, MTM-H-001 Injection, 5 dose groups are planned; the study treatment period includes an induction phase and a maintenance phase. Part B: Dose Expansion Part, MTM-H-001 Injection, 6 dose cohorts are planned. The dose and frequency for each cohort will be determined based on the safety, PK, and PD data of participants from the dose groups in Part A |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MTM-H-001 Injection | Drug | Each participant receives MTM-H-001 Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Dose-Limiting Toxicity (DLT) | Percentage of participants experiencing DLTs | 42 days following first dose of MTM-H-001 for each participant |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Throughout the study, up to 12 months for each participant |
| Change from baseline in Physician Global Assessment (PhGA) |
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Inclusion Criteria:
Key inclusion criteria include:
Exclusion Criteria:
Key exclusion criteria include:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Pan, Ph.D | Contact | +86-010-50847588 | 869 | panj@gobroadhealthcare.com |
| Yusha Huang | Contact | yushahuang@MagicTimeMed.onmicrosoft.com |
| Name | Affiliation | Role |
|---|---|---|
| Jing Pan, Ph.D | Beijing GoBroad Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing GoBroad Hospital | Beijing | Beijing Municipality | 102206 | China |
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Change of Physician Global Assessment (PhGA) score from baseline |
| 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 | Throughout the study, up to 12 months for each participant |
| ID | Term |
|---|---|
| D008181 | Lupus Nephritis |
| D009103 | Multiple Sclerosis |
| D009157 | Myasthenia Gravis |
| D000077733 | Immunoglobulin G4-Related Disease |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008180 | Lupus Erythematosus, Systemic |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D020361 | Paraneoplastic Syndromes, Nervous System |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010257 | Paraneoplastic Syndromes |
| D019636 | Neurodegenerative Diseases |
| D020511 | Neuromuscular Junction Diseases |
| D009468 | Neuromuscular Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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