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

NCT07526493 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2026-05-12

No results posted yet for this study

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)
  • Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
  • Myasthenia Gravis (MG)
  • Anti-Myelin Oligodendrocyte Glycoprotein Immunoglobulin G Antibody-Associated Disease (MOGAD)
  • Idiopathic Inflammatory Myopathies (IIM)

Interventions

BIOLOGICAL

Universal CD19 CAR-γδT Cell Injection

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

DRUG

Cyclophosphamide

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

DRUG

Fludarabine

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

Sponsors & Collaborators

  • Tongji Hospital

    lead OTHER

Principal Investigators

  • Daishi Tian · Tongji Hospital

  • Chuan Qin · Tongji Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07526493 on ClinicalTrials.gov