Safety and Preliminary Efficacy of HN2302 in Patients With Autoimmune Diseases
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-69
SponsorShenzhen MagicRNA Biotechnology Co., Ltd
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
HN2302 Injection
DrugDosing will begin at a lower dose level and may be escalated to dose levels considered safe and potentially effective according to the study protocol.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: HN2302 treatment groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
1
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 days2
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 months3
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 months4
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Shenzhen MagicRNA Biotechnology Co., Ltd
Lead sponsor
The First Affiliated Hospital of University of Science and Technology of China
Collaborator
Source ClinicalTrials.gov
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