Safety and Pharmacodynamics of QH103 Cell Injection in the Treatment of Patients With Relapsed/Refractory Antibody-Mediated Neurological Autoimmune Diseases.
Recruiting now · Phase 1
Conditions studied: Multiple Sclerosis (MS), Neuromyelitis Optica Spectrum Disorder (NMOSD), Autoimmune Encephalitis (AE), Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Myasthenia Gravis (MG), Anti-Myelin Oligodendrocyte Glycoprotein Immunoglobulin G Antibody-Associated Disease (MOGAD), Idiopathic Inflammatory Myopathies (IIM)
In brief
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.
Key facts
- Study ID
- NCT07526493
- Run by
- Tongji Hospital
- People needed
- 6
- Starts
- 2026-04-01
- Expected to finish
- 2028-12-31
- Last updated by the study team
- 2026-05-12
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- History of severe drug allergy or allergic diathesis.
- Presence of or suspected uncontrolled or treatment-requiring fungal, bacterial, viral, or other infections.
- Organ function that does not meet the following requirements (except for abnormalities caused by the autoimmune disease itself):
- Bone Marrow Function: White blood cell count ≥1×10⁹/L; absolute neutrophil count ≥1×10⁹/L (no treatment with colony-stimulating factors within 2 weeks prior to the test); hemoglobin ≥60 g/L.
- Liver Function: ALT ≤3×ULN (except if elevated due to inflammatory myopathy); AST ≤3×ULN (except if elevated due to inflammatory myopathy); Indirect bilirubin (IBIL) ≤1.5×ULN (except for Gilbert's syndrome); Total bilirubin ≤3.0×ULN.
- Renal Function: Creatinine clearance (CrCl) ≥30 mL/min (eGFR ≥30 mL/min/1.73m²) (calculated by Cockcroft-Gault formula, except for acute decreases in CrCl due to the disease itself).
- Coagulation Function: International normalized ratio (INR) ≤1.5×ULN; Prothrombin time (PT) ≤1.5×ULN.
- Cardiac Function: Left ventricular ejection fraction (LVEF) ≥55% and no clinically significant cardiac disease.
- Subjects with a history indicative of congenital immunoglobulin deficiency.
- History of active/unresolved malignant tumors within the past 5 years.
- Subjects who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA titer above the detection limit; positive for hepatitis C virus (HCV) antibody with detectable peripheral blood HCV RNA; positive for human immunodeficiency virus (HIV) antibody; or positive for Treponema pallidumserology.
- History of definite psychiatric disorders or history of substance abuse involving psychotropic drugs that cannot be discontinued.
- Participation in any other 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 (e.g.,Crohn's disease, systemic lupus erythematosus) that, within the past 2 years, have resulted in end-organ damage or required systemic immunosuppressive therapy (excluding the disease populations specified for enrollment in the study protocol).
- Myasthenia gravis crisis not effectively controlled within 2 weeks prior to enrollment.
- History of cerebrovascular accident, including transient ischemic attack or stroke, within 6 months prior to enrollment.
- Male or female participants unwilling to practice contraception from the time of informed consent until 6 months after treatment completion.
- Any medical condition that may interfere with the assessment of the safety or efficacy of the study treatment.
- History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to enrollment, requiring systemic anticoagulation therapy.
- Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation in this study.
Where it is running
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (enrolling)
Full record on ClinicalTrials.gov
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