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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 lable and single arm study, is designed to evaluate the safety and preliminary efficacy of HN2301 in Autoimmune Disease(AID)
This study is a prospective exploratory clinical trial in subjects with Autoimmune Disease(SLE, SSc, RA, etc.). The objective is to evaluate the safety and efficacy of HN2301 injection in Autoimmune Disease (SLE, SSc, RA, etc.).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HN2301 treatment group | Experimental | Participants will receive HN2301 Injection at the specified dose level and on the specified study days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HN2301 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 |
|---|---|---|
| vivo CAR T cell production | CAR T production in the peripheral blood of AID patients, by flow cytometry (FACS), and quantitative polymerase chain reaction (qPCR) in peripheral blood | Day-28 to14 days |
| B cell ratio and counts in peripheral blood |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhu Chen, MD | Contact | +86055162284920 | doczchen@ustc.edu.cn | |
| Ze Xiu Xiao, MD | Contact | +86075527109036 | xiaozexiu@magicrna.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhu Chen, MD | 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 | Recruiting | Hefei | Anhui | China |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D045743 | Scleroderma, Diffuse |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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Assessment of B cell ratio and counts (B cell counts per μl peripheral blood) and B cell subsets(naive B cell, memory B cell) by flow cytometry (FACS) in peripheral blood
| Day-28 to12 months |
| Change from baseline of SLEDAI-2K score after HN2301 administration. | Assessment of Systemic Lupus Erythematosus Disease Activity Index 2000 from baseline administration at various timepoints up to month 12 follow-up visit. A total score can fall between 0 and 105, with a higher score representing a more significant degree of disease activity. | Day-28 to12 months |
| Quantify the clinical activity of HN2301 in patients using Physician Global Assessment (PGA) . | Assessment of Physician Global Assessment (PGA) from baseline administration at various timepoints up to month 12 follow up visit. A total score can fall between 0.0 and 3.0, with a higher score representing a more significant degree of disease activity. | Day-28 to12 months |
| Proportion of participants achieving lupus low disease activity status (LLDAS) | Proportion of participants who achieve LLDAS at scheduled visits through Month 12. | Day-28 to12 months |
| Proportion of patients achieving DORIS remission after HN2301 administration | Assessment of DORIS response rate at various timepoints up to the month 12 follow-up visit. | Day-28 to12 months |
| Assess the clinical activity of HN2301 in patients with SLE using Systemic Lupus Erythematosus Responder Index-4 (SRI-4) | Assessment of whether participants meet the Systemic Lupus Erythematosus Responder Index-4 (SRI-4) criteria (yes/no) at various timepoints up to the month 12 follow-up visit. | Day-28 to12 months |
| Proportion of patients achieving complete renal response (CRR) after HN2301 administration | Proportion of patients achieving complete renal response (CRR) after HN2301 administration | Day-28 to12 months |
| Changes from baseline in Patient Global Assessment(PtGA) scores | 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 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 |
| Changes from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) score | 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 |
| Changes from baseline in Disease Activity Score (DAS28) score | Proportion of patients disease activity changes, a scale from 0 to 10 indicating the current activity of the rheumatoid arthritis. A DAS28 above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. | Up to 12 months |
| Changes from baseline in Visual Analogue Scale (VAS) score | A total score can fall between 0 and 10 | Up to 12 months |
| D012595 | Scleroderma, Systemic |
| D012871 | Skin Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |