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| Name | Class |
|---|---|
| The First Affiliated Hospital of University of Science and Technology of China | OTHER |
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This is an open-label, single-arm study designed to evaluate the safety and preliminary efficacy of HN2302 in patients with autoimmune diseases, including systemic lupus erythematosus (SLE) and systemic sclerosis (SSc).
The study consists of a screening period of up to 4 weeks, a treatment period, and a follow-up period of 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HN2302 treatment group | Experimental | Participants will receive HN2302 Injection at the specified dose level and on the specified study days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HN2302 Injection | Drug | Dosing will begin at a lower dose level and may be escalated to dose levels considered safe and potentially effective according to the study protocol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events (TEAEs) | Incidence, nature, and severity of treatment-emergent adverse events, assessed according to the study protocol and applicable toxicity grading criteria. | Up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| in vivo CAR T cell production | Assessment of in vivo CAR-T cell production, defined by the proportion of CAR-expressing T cells in peripheral blood as measured by flow cytometry. | Up to14 days |
| B-cell proportion and absolute count in peripheral blood |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhu Chen | Contact | +86055162284920 | doczchen@ustc.edu.cn | |
| Zexiu Xiao | Contact | +86075527109036 | xiaozexiu@magicrna.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhu Chen | The First Affiliated Hospital of University of Science and Technology of China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of University of Science and Technology of China | Hefei | Anhui | 230036 | China |
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| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| D008180 | Lupus Erythematosus, Systemic |
| D012595 | Scleroderma, Systemic |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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Assessment of peripheral blood B-cell proportion, absolute B-cell count (cells/μL), and B-cell subsets, including naive B cells and memory B cells, by flow cytometry.
| Up to 12 months |
| Change from baseline in SLEDAI-2K score | Assessment of change from baseline in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K). Total scores range from 0 to 105, with higher scores indicating greater disease activity. | Up to 12 months |
| Change from baseline in Physician Global Assessment (PGA) | Assessment of change from baseline in Physician Global Assessment (PGA) at scheduled visits through Month 12. Scores range from 0.0 to 3.0, with higher scores indicating greater disease activity. | Up to 12 months |
| Proportion of participants achieving lupus low disease activity status (LLDAS) | Proportion of participants who achieve LLDAS at scheduled visits through Month 12 | Up to 12 months |
| Proportion of patients achieving DORIS remission | Proportion of participants who achieve Definitions of Remission in SLE (DORIS) remission at scheduled visits through Month 12. | Up to 12 months |
| Proportion of participants achieving SRI-4 response | Proportion of participants who meet the criteria for the Systemic Lupus Erythematosus Responder Index-4 (SRI-4) at scheduled visits through Month 12. | Up to 12 months |
| Changes from baseline in Patient Global Assessment （PtGA） | Assessment of change from baseline in Patient Global Assessment (PtGA) of overall disease activity at scheduled visits through Month 12. Typically on a 0 to 10 numeric scale, where 0 indicates no disease activity and 10 represents the worst possible activity. | Up to 12 months |
| Change from baseline in British Isles Lupus Assessment Group 2004 (BILAG-2004) index | Assessment of change from baseline in the BILAG-2004 index. The BILAG-2004 index evaluates 97 clinical manifestations of SLE across 9 organ domains, with activity in each domain graded from A to E, the activity level of the disease respond to the score. | Up to 12 months |
| Change from baseline in modified Rodnan Skin Score (mRSS) | Assessment of change from baseline in modified Rodnan Skin Score (mRSS). Total scores range from 0 to 51, with higher scores indicating greater skin thickening. | Up to 12 months |
| Change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) | Assessment of change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI), a patient-reported measure of functional ability across 8 domains, the patient responds on a scale of 0 (no disability) to 3 (completely disabled). | Up to 12 months |
| Change from baseline in revised Composite Response Index in Systemic Sclerosis (r-CRISS) score | Assessment of change from baseline in the revised Composite Response Index in Systemic Sclerosis (r-CRISS), a weighted composite score based on 5 core measures of disease status, improved by a certain percentage in ≥3 of 5 core set measures. | Up to 12 months |