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Not yet recruiting NCT07523282

Safety and Preliminary Efficacy of HN2302 in Patients With Autoimmune Diseases

Phase I Interventional Autoimmune Disease Systemic Lupus Erythematosus Systemic Sclerosis (SSc)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HN2302 Injection.
Who it may be relevant to
Registry conditions: Autoimmune Disease, Systemic Lupus Erythematosus, Systemic Sclerosis (SSc). Basic parameters: 18 years — 69 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Study to Assess the Safety and Preliminary Efficacy of HN2302 in Patients With Autoimmune Diseases

Overview

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).

Detailed description

The study consists of a screening period of up to 4 weeks, a treatment period, and a follow-up period of 1 year.

Interventions

  • Drug HN2302 Injection
    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.

Primary outcome measures

  • Incidence of treatment-emergent adverse events (TEAEs) [Time frame: Up to 3 months]
Secondary outcome measures (12)
  • in vivo CAR T cell production [Time frame: Up to14 days]
  • B-cell proportion and absolute count in peripheral blood [Time frame: Up to 12 months]
  • Change from baseline in SLEDAI-2K score [Time frame: Up to 12 months]
  • Change from baseline in Physician Global Assessment (PGA) [Time frame: Up to 12 months]
  • Proportion of participants achieving lupus low disease activity status (LLDAS) [Time frame: Up to 12 months]
  • Proportion of patients achieving DORIS remission [Time frame: Up to 12 months]
  • Proportion of participants achieving SRI-4 response [Time frame: Up to 12 months]
  • Changes from baseline in Patient Global Assessment （PtGA） [Time frame: Up to 12 months]
  • Change from baseline in British Isles Lupus Assessment Group 2004 (BILAG-2004) index [Time frame: Up to 12 months]
  • Change from baseline in modified Rodnan Skin Score (mRSS) [Time frame: Up to 12 months]
  • Change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) [Time frame: Up to 12 months]
  • Change from baseline in revised Composite Response Index in Systemic Sclerosis (r-CRISS) score [Time frame: Up to 12 months]

Eligibility criteria

Inclusion criteria

  • Adults aged 18 to 69 years, regardless of gender.
  • Adequate bone marrow, coagulation, cardiopulmonary, hepatic, and renal function.
  • Participants who are not pregnant or breastfeeding and who agree to use effective contraception for 12 months after drug infusion, if applicable.
  • Diagnosis of systemic lupus erythematosus (SLE) according to the 2019 EULAR/ACR classification criteria, with a history of SLE for at least 6 months; during screening, participants must have positive antinuclear antibody (ANA), and/or positive anti-double-stranded DNA antibody, and/or hypocomplementemia.
  • Diagnosis of systemic sclerosis (SSc) according to the 2013 ACR/EULAR classification criteria, including limited cutaneous or diffuse cutaneous systemic sclerosis, with new or progressive skin manifestations within 6 months before screening.

Exclusion criteria

  • Positive hepatitis B surface antigen (HBsAg), or positive hepatitis B core antibody (HBcAb) with detectable or quantifiable HBV DNA; positive hepatitis C antibody with detectable or quantifiable HCV RNA; positive HIV antibody; positive CMV DNA; or positive syphilis antigen or antibody.
  • Presence of any other uncontrolled active infection.
  • History of major solid organ transplantation (for example, heart, lung, liver, or kidney transplantation) or bone marrow/hematopoietic stem cell transplantation.
  • Pregnant or breastfeeding women.
  • Receipt of any mRNA-LNP product or other LNP-based drug within the past 2 years.
  • History, within 6 months before screening, of any of the following cardiovascular conditions: NYHA Class III or IV heart failure, myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmia, ventricular arrhythmia, or other clinically significant cardiac disease.
  • Receipt of a live vaccine within 30 days before screening.
  • History of asthma or severe allergy, if considered clinically significant by the investigator.
  • Any condition that, in the investigator's opinion, would increase risk to the participant or interfere with study assessments.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Affiliated Hospital of University of Science and Technology of China — Hefei

Identifiers

NCT: NCT07523282 · HN2302-N01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗