Evaluate the Safety and Efficacy of CAR-T Cells in the Treatment of Refractory Myasthenia Gravis

A Study on the Safety and Efficacy of Chimeric Antigen Receptor T Cells in the Treatment of Refractory Myasthenia Gravis

Evaluate the Safety and Efficacy of CAR-T Cells in the Treatment of Refractory Myasthenia Gravis (NCT05828225) is a Phase 1 interventional studying Myasthenia Gravis, sponsored by Zhejiang University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Myasthenia Gravis, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 9 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - 1\. Age ≥18 and gender unlimited； - 2\. Confirmed as refractory myasthenia gravis with AchR antibody positive and accord one of the following three conditions 1. Repeated electrical stimulation suggests neuromuscular conduction deficits； 2. Tensilon test and neostigmine test positive; 3. The doctor judged that the symptoms of MG improved after treatment with oral cholinease inhibitors; - 3\. Consistent with the clinical classification of MGFA myasthenia gravis IIa-IVb (including IIa，IIb，IIIa， IIIb， IVa，IVb) - 4\. The baseline MG-ADL score ≥5 and the musculi oculi related score\< 50 ； - 5\. Baseline QMG score\>11; - 6\. Regular treatment with poor efficacy and/or lack of effective treatment means that there is still recurrence or exacerbation after treatment with conventional hormones, immunosuppressants (such as azathioprine, mycophenolate mofetil, tacrolimus, cyclosporine A, cyclophosphamide, etc.) or rituximab； - 7\. The estimated survival time is more than 12 weeks; - 8\. Women of childbearing age who have negative urine pregnancy test before medication administration and agree to take effective contraceptive measures during the trial period until the last follow-up. Who Should NOT Join This Trial: - 1\. Epilepsy history or other central nervous system disease; - 2\. During the screening visit, the patient's thymectomy was less than 12 months or thymectomy was necessary during the study period or thymic radiation therapy ; - 3\. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythm ia in the past; - 4\. Pregnant (or lactating) women; - 5\. Patients with severe active infections; - 6\. Active infection of hepatitis B virus or hepatitis C virus; - 7\. Systemic steroids have used in the 4 weeks before participating in the treatment (except recently or currently using inhaled steroids); - 8\. Those who have used any gene therapy products before; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * 1\. Age ≥18 and gender unlimited； * 2\. Confirmed as refractory myasthenia gravis with AchR antibody positive and accord one of the following three conditions 1. Repeated electrical stimulation suggests neuromuscular conduction deficits； 2. Tensilon test and neostigmine test positive; 3. The doctor judged that the symptoms of MG improved after treatment with oral cholinease inhibitors; * 3\. Consistent with the clinical classification of MGFA myasthenia gravis IIa-IVb (including IIa，IIb，IIIa， IIIb， IVa，IVb) * 4\. The baseline MG-ADL score ≥5 and the musculi oculi related score\< 50 ； * 5\. Baseline QMG score\>11; * 6\. Regular treatment with poor efficacy and/or lack of effective treatment means that there is still recurrence or exacerbation after treatment with conventional hormones, immunosuppressants (such as azathioprine, mycophenolate mofetil, tacrolimus, cyclosporine A, cyclophosphamide, etc.) or rituximab； * 7\. The estimated survival time is more than 12 weeks; * 8\. Women of childbearing age who have negative urine pregnancy test before medication administration and agree to take effective contraceptive measures during the trial period until the last follow-up. Exclusion Criteria: * 1\. Epilepsy history or other central nervous system disease; * 2\. During the screening visit, the patient's thymectomy was less than 12 months or thymectomy was necessary during the study period or thymic radiation therapy ; * 3\. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythm ia in the past; * 4\. Pregnant (or lactating) women; * 5\. Patients with severe active infections; * 6\. Active infection of hepatitis B virus or hepatitis C virus; * 7\. Systemic steroids have used in the 4 weeks before participating in the treatment (except recently or currently using inhaled steroids); * 8\. Those who have used any gene therapy products before; * 9\. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal; * 10\. Serum creatinine \> 2.5mg/dl or ALT / AST \> 3 times ULN or bilirubin \> 2.0 mg /dl; * 11\. Those who suffer from other uncontrolled diseases are not suitable to join the study; * 12\. HIV infection; * 13\. Any situation that the researchers believe may increase the risk of patients or interfere with the test results.

Treatments Being Tested

DRUG

CD19 CAR-T cells injection

CD19 CAR-T in the Treatment of Refractory Myasthenia Gravis

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

The first affiliated hospital of medical college of zhejiang university

Hangzhou, Zhejiang, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05828225), the sponsor (Zhejiang University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05828225 clinical trial studying?

This is a single-arm, open-label, single-center, phase I study. The primary objective is to evaluate the safety of CD19 CAR-T therapy for patients with refractory myasthenia gravis, and to evaluate the pharmacokinetics of CD19 CAR-T in patients. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05828225?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05828225?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05828225. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05828225. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.