New CAR-T therapy aims to calm overactive immune system in muscle weakness disease
NCT ID NCT07556120
First seen Jun 27, 2026 · Last updated Aug 13, 2026 · Updated 2 times
Summary
This early study tests a new treatment called HN2301 in 6 adults with generalized myasthenia gravis, a disease that causes muscle weakness. The treatment uses the body's own immune cells to target and reduce harmful immune activity. The main goal is to check safety and see how well the body tolerates it.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 6 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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; * Patients combined with other malignant tumors; * Any condition that, in the investigator's opinion, may increase the patient's risk or interfere with study assessments.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, 230036, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new drug offer Long-Term relief for muscle weakness?
- Can a new drug ease the muscle weakness of myasthenia gravis?
- Engineered immune cells take aim at debilitating muscle weakness
- New hope for myasthenia gravis: experimental drug CNP-106 enters human trials
- New hope for myasthenia gravis patients: experimental drug enters phase 2 trial
- New drug trial aims to ease muscle weakness in rare disease