Actively Recruiting
Safety and Pharmacodynamics of QH103 Cell Injection in the Treatment of Patients With Relapsed/Refractory Antibody-Mediated Neurological Autoimmune Diseases.
Led by Tongji Hospital · Updated on 2026-05-12
6
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is an open-label, exploratory, prospective clinical trial with dose escalation(according to "3+3" design), to evaluate the safety and tolerability of QH103(Universal CD19 CAR-γδT Cell Injection)in the treatment of recurrent/refractory antibody-mediated neurological autoimmune diseases.
CONDITIONS
Official Title
Safety and Pharmacodynamics of QH103 Cell Injection in the Treatment of Patients With Relapsed/Refractory Antibody-Mediated Neurological Autoimmune Diseases.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18-75 years, any gender
- Female participants of childbearing potential and males with partners of childbearing potential must use approved contraception or abstinence during treatment and for 6 months after
- Female participants of childbearing potential must have a negative serum HCG test within 7 days before enrollment and not be breastfeeding
- Expected survival of at least 12 weeks as judged by the investigator
- Voluntary participation with signed informed consent
- Diagnosis of one of the following with disease-specific criteria: progressive or relapsing-remitting multiple sclerosis with EDSS 2-7; AQP4 antibody-positive neuromyelitis optica spectrum disorder; autoimmune encephalitis with relevant autoantibody and recent episode; antibody-positive chronic inflammatory demyelinating polyneuropathy with disability score 2-9; antibody-positive myasthenia gravis MGFA Class II-IV with MG-ADL score ≥6; MOG antibody-associated disease with mRS score ≥2; refractory antibody-positive idiopathic inflammatory myopathies with elevated muscle enzymes or active myositis and positive specific antibodies
- Disease-specific treatment history and symptom control criteria as detailed in protocol
You will not qualify if you...
- History of severe drug allergy or allergic tendency
- Uncontrolled or treatment-requiring infections
- Impaired organ function beyond disease-related abnormalities including bone marrow, liver, kidney, coagulation, and heart function as specified
- History of congenital immunoglobulin deficiency
- Active or unresolved malignancy within 5 years
- Positive for hepatitis B, hepatitis C, HIV, or syphilis with detectable viral load
- History of significant psychiatric disorders or substance abuse
- Participation in other clinical trials within 3 months prior
- Prior CAR-T cell therapy
- Severe adverse reactions to cyclophosphamide or fludarabine
- Other autoimmune diseases causing organ damage or requiring systemic immunosuppression in past 2 years (except study diseases)
- Uncontrolled myasthenia gravis crisis within 2 weeks
- Recent stroke or transient ischemic attack within 6 months
- Unwillingness to practice contraception during study and for 6 months after
- Medical conditions interfering with safety or efficacy assessment
- History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months requiring anticoagulation
- Any other condition judged unsuitable by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Actively Recruiting
Research Team
D
Daishi Tian
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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