Actively Recruiting
GC012F Injection in the Treatment of Refractory Generalized Myasthenia Gravis(24103)
Led by Daishi Tian · Updated on 2025-09-08
6
Participants Needed
1
Research Sites
112 weeks
Total Duration
On this page
Sponsors
D
Daishi Tian
Lead Sponsor
G
Gracell Biotechnologies (Shanghai) Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a single-arm, open-label and early exploratory clinical study, with the purpose to study the safety, tolerability and initial clinical efficacy of GC012F Injection in the treatment of refractory GMG and to evaluate the PK, PD characteristics and immunogenicity in subjects with refractory GMG infused with GC012F Injection.
CONDITIONS
Official Title
GC012F Injection in the Treatment of Refractory Generalized Myasthenia Gravis(24103)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects or their legal representatives voluntarily sign informed consent and agree to comply with study procedures
- Aged 18 to 75 years, any gender
- Confirmed refractory generalized myasthenia gravis classified as IIa to IVb by MGFA at screening
- MG-ADL score of 6 or higher with less than 50% ocular symptoms and QMG score of 11 or higher
- Poor response or no response to conventional treatments including hormones, immunosuppressants, or biological agents
- Stable corticosteroid dose not exceeding 30 mg/day prednisone or equivalent for at least 4 weeks before infusion
- Laboratory test results within specified ranges including neutrophil count, hemoglobin, platelets, liver enzymes, bilirubin, creatinine clearance, coagulation times, and heart function
- Female subjects of child-bearing age must have negative pregnancy test and agree to avoid breastfeeding during study until 1 year post-infusion or as specified
- Male subjects with partners and females of child-bearing potential must agree to effective contraception from screening until 2 years post-infusion or as specified
- Venous access suitable for blood collection and no contraindications to leukocyte collection
You will not qualify if you...
- History of severe hypersensitivity or allergy
- Contraindications or hypersensitivity to fludarabine, cyclophosphamide, or any component of the study drug
- Received intravenous immunoglobulin, plasma exchange, or immunoadsorption therapy within 4 weeks prior to infusion
- Received CD20-targeted drugs within 6 months prior to apheresis
- Received tacrolimus, cyclosporine, azathioprine, or mycophenolate mofetil within 1 week before apheresis
- Treatment with neonatal Fc receptor antagonists within 1 week prior to apheresis
- Received complement inhibitors within 1 week before apheresis
- Heart diseases including class III or IV heart failure, unstable angina, recent myocardial infarction or coronary bypass, significant arrhythmias, severe cardiomyopathy, or severe cardiovascular abnormalities
- Other uncontrolled malignancies except certain early-stage or treated tumors
- Serious underlying medical conditions such as uncontrolled infections, dementia, or CNS/neurodegenerative diseases
- Positive tests for HIV, hepatitis B or C with active infection, or syphilis
- Prior treatment with any CAR-T product
- Previous organ or allogeneic bone marrow transplantation
- Surgery within 2 weeks before lymphodepletion or planned surgery during study except minor local anesthesia procedures
- Received live attenuated vaccine within 4 weeks prior to lymphodepletion
- Participation in other clinical trials with investigational drugs within 4 weeks prior to consent or as specified
- Pregnant or lactating females who do not agree to avoid breastfeeding or men with family plans within 1 year of treatment
- Current suicidal intentions or history of suicidal behavior
- Other conditions judged by the investigator to prevent full participation or affect study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tongji Hospital of Tongji Medical Colledge, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Actively Recruiting
Research Team
C
Chuan Qin Sub-I
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here