Refractory Myasthenia GravisNCT07413835
Efficacy and Safety of HN2302 in Refractory Myasthenia Gravis(MG)
A study testing HN2302 Injection in people with Refractory Myasthenia Gravis, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.
Trial summary
This is an open label, single arm study, to evaluate the safety , tolerability and preliminary efficacy of HN2302 for refractory myasthenia gravis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Refractory Myasthenia Gravis
- What is being tested?
- HN2302 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 17 Mar 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
- Any condition that, in the investigator's opinion, may increase the patient's risk or interfere with study assessments.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000
Yong Zhang, 86-0516-85802193, zy20037416@163.com
About this study
Official title: A Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of HN2302 in Patients With Refractory Myasthenia Gravis
This is an open label, single arm study, to evaluate the safety , tolerability and preliminary efficacy of HN2302 for refractory myasthenia gravis.
Read the detailed description
The study will consist of an up to 4-week Screening Period, Treatment Period and one year Follow-up Period.
- Conditions
- Refractory Myasthenia Gravis
- Being tested
- HN2302 Injection
- Keywords
- MG, HN2302
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HN2302 InjectionDrug
Also called in vivo CAR-T
Patients will be administrated with specified dose on specified days at a lower dose level and escalated to safe and effective dose levels.
| Study group | Role | What they receive |
|---|---|---|
| HN2302 treatment group | Experimental | Started at a lower dose level Receives: Drug: HN2302 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Proportion and severity of adverse events (AEs)
Measured: Up to 3 months
Secondary outcomes (9)
Changes from baseline in Myasthenia Gravis Activities of Daily Living（MG-ADL） score
Proportion of patients ≥2 points. A total score can fall between 0 and 24, with a higher score representing a more significant degree of disease activity
Measured: Up to 12 months
Changes from baseline in Myasthenia Gravis Composite （MGC） score
Proportion of patients ≥3-point reduction.The total score is 50 points. The higher the score, the more severe the condition is indicated.
Measured: Up to 12 months
Changes from baseline in Quantitative Myasthenia Gravis (QMG) score
Proportion of patients ≥3-point reduction. To assess the muscle strength and endurance of the affected muscles in patients with myasthenia gravis, thereby reflecting the severity of the disease.
Measured: Up to 12 months
Changes from baseline in 15-item quality of life (MG-QOL15r) score
To assess important aspects of the patient's experience related to MG, scores each of 15 items 0-2 (max score 30).
Measured: Up to 12 months
Percentage of patients with symptom changes after treatment
Proportion of patients without symptom worsening or relapse
Measured: Up to 12 months
in vivo CAR T cell production
Assessment of CAR T production (CAR expression ratio in T cells) in the peripheral blood of MG patients by flow cytometry (FACS)
Measured: Day-28 to14 days
B cell ratio and counts in peripheral blood
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
Measured: Up to 12 months
Dynamic changes in cytokine levels after treatment
Differences in cytokine post-administration vs. baseline
Measured: Up to 12 months
Changes in acetylcholine receptor (AchR) antibody levels after treatment
Differences in AchR antibody post-administration vs. baseline
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start17 Mar 2026
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Myasthenia GravisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen MagicRNA Biotechnology Co., Ltd
- Responsible party
- Sponsor
- Investigators
- Guiyun Cui, Principal investigator, The Affiliated Hospital of Xuzhou Medical UniversityYong Zhang, Principal investigator, The Affiliated Hospital of Xuzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07413835
- Sponsor's protocol ID
- HN2302-N04
- Status last verified
- Mar 2026
- First submitted
- 3 Feb 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of HN2302 in Patients With Refractory Myasthenia Gravis
- ClinicalTrials.gov ID
- NCT07413835
- Acronym / sponsor ID
- HN2302-N04
- Conditions
- Refractory Myasthenia Gravis
- Keywords
- MG, HN2302
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical UniversityUniversity, hospital or other
- Collaborators
- Shenzhen MagicRNA Biotechnology Co., Ltd
- Study start
- 17 Mar 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HN2302 treatment group | Experimental | Drug: HN2302 InjectionStarted at a lower dose level |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HN2302 InjectionAlso: in vivo CAR-TPatients will be administrated with specified dose on specified days at a lower dose level and escalated to safe and effective dose levels. | Drug | HN2302 treatment group |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: Up to 3 months
Proportion and severity of adverse events (AEs)
9 secondary outcomes
Changes from baseline in Myasthenia Gravis Activities of Daily Living（MG-ADL） score
Time frame: Up to 12 months
Changes from baseline in Myasthenia Gravis Composite （MGC） score
Time frame: Up to 12 months
Changes from baseline in Quantitative Myasthenia Gravis (QMG) score
Time frame: Up to 12 months
Changes from baseline in 15-item quality of life (MG-QOL15r) score
Time frame: Up to 12 months
Percentage of patients with symptom changes after treatment
Time frame: Up to 12 months
in vivo CAR T cell production
Time frame: Day-28 to14 days
B cell ratio and counts in peripheral blood
Time frame: Up to 12 months
Dynamic changes in cytokine levels after treatment
Time frame: Up to 12 months
Changes in acetylcholine receptor (AchR) antibody levels after treatment
Time frame: Up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guiyun Cui principal investigator
The Affiliated Hospital of Xuzhou Medical University
Yong Zhang principal investigator
The Affiliated Hospital of Xuzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HN2302 Injection in people with Refractory Myasthenia Gravis, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yong Zhang (86-0516-85802193, zy20037416@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.