Safety and Pharmacodynamics of QH103 Cell Injection in the Treatment of Patients With Relapsed/Refractory Antibody-Mediated Neurological Autoimmune Diseases.

ConditionsMultiple 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)

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-75

SponsorTongji Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

History of severe drug allergy or allergic diathesis.

Presence of or suspected uncontrolled or treatment-requiring fungal, bacterial, viral, or other infections.

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.

Trial design

Treatments tested in this trial

Universal CD19 CAR-γδT Cell Injection
Cyclophosphamide
Fludarabine

Treatment groups

6 Participants

are divided into 1 treatment group

Sponsors and collaborators

Tongji Hospital

Lead sponsor

Source ClinicalTrials.gov