Safety and Pharmacodynamics of QH103 Cell Injection in the Treatment of Patients With Relapsed/Re… (NCT07526493) | Clinical Trial Compass
RecruitingPhase 1
Safety and Pharmacodynamics of QH103 Cell Injection in the Treatment of Patients With Relapsed/Refractory Antibody-Mediated Neurological Autoimmune Diseases.
China6 participantsStarted 2026-04-01
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Aged 18-75 years (inclusive), any gender.
✓. Female subjects of childbearing potential and male subjects 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 the end of the study treatment. Female subjects of childbearing potential must have a negative serum HCG test within 7 days before study enrollment and must not be breastfeeding.
✓. The subject's expected survival, as judged by the investigator, is ≥12 weeks.
✓. Voluntarily participate in this trial and sign the informed consent form.
✓. Two relapses were recorded within the first 2 years of screening;
✓. One recurrence was recorded within the first year prior to screening;
✓. Select the results of Gd-enhanced MRI scans that were positive within the previous year (if there is no record of a positive Gd-enhanced scan in the previous year, the results of the screening MRI scan can be used).
✓. Treatment with at least one immunosuppressant for over 1 year, or intolerance to immunosuppressant treatment, with suboptimal symptom control.
Exclusion criteria
✕. History of severe drug allergy or allergic diathesis.
✕. Presence of or suspected uncontrolled or treatment-requiring fungal, bacterial, viral, or other infections.
What they're measuring
1
Incidence of Dose-Limiting Toxicities (DLTs)
Timeframe: First infusion date of QH103 up to 28 days
. 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.