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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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Universal CD19 CAR-γδT Cell Injection

    Biological/Vaccine

    Biological: Allogeneic CD19 CAR-γδT cell following lymphodepletion with chemotherapy (cyclophosphamide and fludarabine) patients will be treated

  • Cyclophosphamide

    Drug

    Subjects will receive cyclophosphamide infusion on Days -5 to -3 prior to cell infusion.

  • Fludarabine

    Drug

    Subjects will receive fludarabine infusion on Days -5 to -3 prior to cell infusion.

Treatment groups

6 Participants
are divided into 1 treatment group
Group A: Patients with Relapsed/Refractory Antibody-Mediated Neurological Autoimmune DiseasesExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Incidence of Dose-Limiting Toxicities (DLTs)

DLT was defined as QH103-related events with onset within first 28 days.

Time frame
First infusion date of QH103 up to 28 days
2

Adverse Event

AE is defined as any adverse medical event from the date the subject receives lymphodepleting chemotherapy to 12months after QH103 infusion. Among them, cytokine release syndrome (CRS) and immune cell-associated neurotoxicity syndrome (ICANS) were graded according to American Society for Transplantation and Cellular Therapy (ASTCT) criteria, graft-versushost disease (GVHD) according to criteria defined by the Mount Sinai Acute GVHD International Consortium. Other AEs were graded according to common terminology criteria for adverse events (CTCAE) v5.0

Time frame
12 months

Secondary outcomes

1

PK(Pharmacokinetics): Number and Copy Number of CD19 CAR-γδT cells

Number and copy number of CD19 CAR-γδT cells were assessed by number in peripheral blood. Blood samples were collected before and one year after cell infusion (until CD19 CAR-γδT cells were not detected for two consecutive times) to detect the number and copy number of CD19 CAR-γδT cells, and to evaluate the pharmacokinetics of CD19 CAR-γδT.

Time frame
12 months
2

PD(Pharmacodynamics) ：Changes in cytokines and chemokines over time

Changes in cytokines and chemokines (such as IL-2, IL-4, IL-6, IFN-γ, and TNF-α) over time

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tongji Hospital

Lead sponsor

Source ClinicalTrials.gov
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