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Clinical Trials/NCT07413835
NCT07413835
Recruiting
Not Applicable

A Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of HN2302 in Patients With Refractory Myasthenia Gravis

The Affiliated Hospital of Xuzhou Medical University1 site in 1 country6 target enrollmentStarted: March 17, 2026Last updated:
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InterventionsHN2302 Injection

Overview

Phase
Not Applicable
Status
Recruiting
Enrollment
6
Locations
1
Primary Endpoint
Incidence of Treatment-Emergent Adverse Events
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

This is an open label, single arm study, to evaluate the safety , tolerability and preliminary efficacy of HN2302 for refractory myasthenia gravis.

Detailed Description

The study will consist of an up to 4-week Screening Period, Treatment Period and one year Follow-up Period.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Age: 18-80 years, no gender restriction;
  • •Confirmed diagnosis of generalized myasthenia gravis (MG) with positive AchR or MuSK antibodies, meeting at least one of the following conditions：(1) Repetitive nerve stimulation suggesting neuromuscular transmission defect; (2) Positive response to neostigmine test; (3) Clinically judged improvement of --MG symptoms after oral cholinesterase inhibitor therapy;
  • •Clinical classification of MG according to MGFA types IIa-IVb (including IIa, IIb, IIIa, IIIb, IVa, IVb);
  • •Baseline MG-ADL score ≥6, ocular-related score \<50%;
  • •Poor response and/or lack of efficacy under standard therapies;
  • •Minimum life expectancy \> 12 weeks;
  • •Adequate bone marrow, coagulation, cardiopulmonary, liver, and renal function.

Exclusion Criteria

  • •Subjects positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) with detectable or quantifiable HBV DNA, positive for hepatitis C antibody (HCV Ab) with detectable or quantifiable HCV RNA, positive for HIV antibody, positive CMV DNA, or CMV DNA above the lower limit of detection; positive for syphilis antigen or antibody;
  • •Presence of other uncontrolled active infections;
  • •History of major organ transplantation (e.g., heart, lung, liver, kidney) or bone marrow/hematopoietic stem cell transplantation;
  • •Pregnant or breastfeeding women;
  • •Receipt of any mRNA-LNP products or other LNP-based drugs within the past two years;
  • •History of any of the following cardiovascular conditions within 6 months prior to screening: New York Heart Association (NYHA) Class III or IV heart failure, myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmias, any ventricular arrhythmias, or other clinically significant cardiac disease;
  • •History of ≥Grade 2 bleeding events within 30 days prior to screening, or requiring long-term continuous anticoagulation therapy (e.g., warfarin, low molecular weight heparin, Xa factor inhibitors);
  • •History of live vaccination within 30 days prior to screening;
  • •Severe central nervous system diseases or pathological changes, including but not limited to: cerebrovascular accident, aneurysm, epilepsy, seizures/convulsions, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disorders, organic brain syndromes, or psychosis;
  • •History of asthma or severe allergies;

Arms & Interventions

HN2302 treatment group

Experimental

Started at a lower dose level

Intervention: HN2302 Injection (Drug)

Outcomes

Primary Outcomes

Incidence of Treatment-Emergent Adverse Events

Time Frame: Up to 3 months

Proportion and severity of adverse events (AEs)

Secondary Outcomes

  • Changes from baseline in Myasthenia Gravis Activities of Daily Living（MG-ADL） score(Up to 12 months)
  • Changes from baseline in Myasthenia Gravis Composite （MGC） score(Up to 12 months)
  • Changes from baseline in Quantitative Myasthenia Gravis (QMG) score(Up to 12 months)
  • Changes from baseline in 15-item quality of life (MG-QOL15r) score(Up to 12 months)
  • Percentage of patients with symptom changes after treatment(Up to 12 months)
  • in vivo CAR T cell production(Day-28 to14 days)
  • B cell ratio and counts in peripheral blood(Up to 12 months)
  • Dynamic changes in cytokine levels after treatment(Up to 12 months)
  • Changes in acetylcholine receptor (AchR) antibody levels after treatment(Up to 12 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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