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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
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.
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China
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.
Time frame: Up to 3 months
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.
Time frame: Up to14 days
B-cell proportion and absolute count in peripheral blood
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Up to 12 months
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Proportion of patients achieving DORIS remission
Proportion of participants who achieve Definitions of Remission in SLE (DORIS) remission at scheduled visits through Month 12.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Up to 12 months