Actively Recruiting
Safety and Pharmacodynamics of QH103 Cell Injection in Patients With Relapsed/Refractory Antibody-Mediated Neurological Autoimmune Diseases
Led by Tongji Hospital · Updated on 2026-05-12
6
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of QH103, a Universal CD19 CAR-T cell injection, in treating patients with relapsed or refractory antibody-mediated neurological autoimmune diseases. This open-label, exploratory clinical trial uses a dose escalation approach based on a "3+3" design to study this treatment in adults aged 18 to 75 years. The trial targets various neurological autoimmune conditions, including multiple sclerosis, neuromyelitis optica spectrum disorder, autoimmune encephalitis, chronic inflammatory demyelinating polyneuropathy, myasthenia gravis, MOG antibody-associated disease, and idiopathic inflammatory myopathies. Participants will receive lymphodepletion chemotherapy with cyclophosphamide and fludarabine infusions from five to three days before the cell infusion. Then, they will receive the QH103 cell injection. This phase 1 study monitors participants for adverse events and dose-limiting toxicities within 28 days after the first infusion and follows pharmacokinetics and pharmacodynamics for 12 months. The pharmacodynamics focus on changes in cytokines and chemokines over time, while pharmacokinetics measure the number and copy number of the CD19 CAR-T cells. Throughout the study, participants will be closely monitored with safety assessments and laboratory tests for up to 12 months. Researchers will record any adverse events and evaluate the treatment's impact on immune system markers. Participants must commit to contraception requirements during and after the study. The total study duration and follow-up aim to provide comprehensive data on safety, tolerability, and biological responses to this investigational treatment in this patient population.
CONDITIONS
Brief 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 (inclusive), any gender
- Female participants of childbearing potential and male participants with partners of childbearing potential must use medically approved contraception or practice abstinence during the study treatment period and for at least 6 months after treatment ends
- Female participants of childbearing potential must have a negative serum HCG test within 7 days before enrollment and must not be breastfeeding
- Expected survival of at least 12 weeks as judged by the investigator
- Voluntary participation and signed informed consent
- Diagnosed with one of the following antibody-mediated neurological autoimmune diseases: progressive or relapsing-remitting multiple sclerosis meeting specific relapse or MRI criteria; AQP4 antibody-positive neuromyelitis optica spectrum disorder with suboptimal symptom control or documented relapses; autoimmune encephalitis with positive autoantibodies, recent episode, and defined disability scores; antibody-positive chronic inflammatory demyelinating polyneuropathy with defined disability and inadequate symptom control or intolerance to first-line therapy; antibody-positive myasthenia gravis with MGFA Class II-IV and defined disability scores and treatment history; MOG antibody-associated disease with positive MOG autoantibody and defined disability score and treatment history; refractory antibody-positive idiopathic inflammatory myopathies with specific enzyme levels or disease activity evidence and treatment history
You will not qualify if you...
- History of severe drug allergy or allergic diathesis
- Presence of uncontrolled or treatment-requiring infections
- Bone marrow, liver, renal, coagulation, or cardiac function not meeting specified laboratory or clinical thresholds (except autoimmune disease-related abnormalities)
- History of congenital immunoglobulin deficiency
- Active or unresolved malignancy within past 5 years
- Positive for hepatitis B, hepatitis C, HIV, or syphilis infections with detectable viral load
- History of psychiatric disorders or substance abuse involving psychotropic drugs that cannot be discontinued
- Participation in another clinical trial within 3 months prior to enrollment
- Prior treatment with CAR-T cell therapy
- History of severe adverse reactions to cyclophosphamide or fludarabine
- History of other autoimmune diseases causing end-organ damage or requiring systemic immunosuppressive therapy in past 2 years (excluding study diseases)
- Uncontrolled myasthenia gravis crisis within 2 weeks prior to enrollment
- History of cerebrovascular accident within 6 months prior to enrollment
- Unwillingness to practice contraception from consent until 6 months after treatment
- Medical conditions interfering with safety or efficacy assessment
- History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior requiring systemic anticoagulation
- Other conditions making participation unsuitable as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 days
Participants receive chemotherapy with cyclophosphamide and fludarabine for lymphodepletion prior to cell infusion.
Infusions on Days -5 to -3 prior to cell injection
Duration - Up to 28 days
Participants receive the Universal CD19 CAR-γδT Cell Injection following chemotherapy.
1 infusion visit
Duration - 12 months
Participants are monitored for safety, pharmacokinetics, and pharmacodynamics for up to 12 months after treatment.
Regular visits for safety and assessment over 12 months
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
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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