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

NCT07526493 | Recruiting Phase 1

• 1 other identifier: QH10310-NADs-01（0）
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis (MS); Neuromyelitis Optica Spectrum Disorder (NMOSD); Autoimmune Encephalitis (AE); Idiopathic Inflammatory Myopathies (IIM); Chronic Inflammatory Demyelinating Polyneuropathy (CIDP); Myasthenia Gravis (MG); Anti-Myelin Oligodendrocyte Glycoprotein Immunoglobulin G Antibody-Associated Disease (MOGAD)

Outcome Measures

Primary Outcomes (2)

• Incidence of Dose-Limiting Toxicities (DLTs)

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

  First infusion date of QH103 up to 28 days

• 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

  12 months

Secondary Outcomes (2)

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

  12 months

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

  12 months

Study Arms (1)

Patients with Relapsed/Refractory Antibody-Mediated Neurological Autoimmune Diseases

EXPERIMENTAL

Biological: Universal CD19 CAR-γδT Cell Injection; Drug: Cyclophosphamide; Drug: Fludarabine

Interventions

Cyclophosphamide DRUG

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

Patients with Relapsed/Refractory Antibody-Mediated Neurological Autoimmune Diseases

Fludarabine DRUG

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

Patients with Relapsed/Refractory Antibody-Mediated Neurological Autoimmune Diseases

Universal CD19 CAR-γδT Cell Injection BIOLOGICAL

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

Also known as: QH103 Cell Injection

Patients with Relapsed/Refractory Antibody-Mediated Neurological Autoimmune Diseases

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 、Multiple Sclerosis (MS): Clinically confirmed as progressive MS (including Primary Progressive PPMS or Secondary Progressive SPMS) or Relapsing-Remitting MS (RMS) according to the revised 2017 McDonald criteria. Disability status at screening must meet an EDSS score of 2-7 (inclusive) .For participants with RMS, despite standardized use of DMTs, they must have documented evidence meeting one of the following conditions prior to signing the informed consent:
• 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).
• 、Neuromyelitis Optica Spectrum Disorder (NMOSD): Participants with AQP4 antibody-positive NMOSD meeting the 2015 IPND NMOSD diagnostic criteria, and meeting one of the following:
• Treatment with at least one immunosuppressant for over 1 year, or intolerance to immunosuppressant treatment, with suboptimal symptom control.
• At least 2 documented relapses within the last 12 months, or 3 documented relapses within the last 24 months with at least 1 relapse occurring within the 12 months prior to screening.
• 、Autoimmune Encephalitis (AE): Participants with a clinical diagnosis of Autoimmune Encephalitis based on the 2016 International Diagnostic Criteria, meeting all of the following requirements:
• Positive for at least one relevant autoantibody;
• Inadequate symptom control with or intolerance to previous standardized treatment with glucocorticoids and at least one immunosuppressant/immunomodulator (including CD20 monoclonal antibody);
• An episode of autoimmune encephalitis within 3 months prior to signing the informed consent form;

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.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital

Wuhan, China

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Neuromyelitis Optica; Autoimmune Diseases of the Nervous System; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; Myasthenia Gravis; Myositis

Interventions

Cyclophosphamide; fludarabine

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Myelitis, Transverse; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Eye Diseases; Polyradiculoneuropathy; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Central Study Contacts

Daishi Tian

CONTACT

+86 13607178809; tiands@tjh.tjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of the Department of Neurology, Tongji Hospital

Study Record Dates

• First Submitted: April 3, 2026
• First Posted: April 13, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)