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Anti-CD19-CD3E-CAR-T Cells in Relapsed/Refractory Autoimmune Disease

NCT06373081 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2024-04-18

No results posted yet for this study

Summary

This is an investigator-initiated trial to evaluate the safety and efficacy of anti-CD19-CD3E-CAR-T cells in the relapse or refractory autoimmune diseases.

Conditions

  • Systemic Lupus Erythematosus (SLE)
  • Sjogren's Syndrome
  • Systemic Sclerosis
  • Inflammatory Myopathy
  • ANCA Associated Vasculitis
  • Antiphospholipid Syndrome

Interventions

BIOLOGICAL

Anti-CD19-CD3E-CAR-T cells

The injection of anti-CD19-CD3E chimeric antigen receptor T (CAR-T) cells, referred to as anti-CD19-CD3E-CAR-T cells. The anti-CD19-CD3E-CAR protein is composed of a murine-derived CD19 single-chain variable fragment (scFv) FMC63, CD28 hinge and transmembrane regions, the intracellular domain of CD3E, the intracellular domain of CD28, and the intracellular domain of CD3ζ, all linked in sequence.

Sponsors & Collaborators

  • Shanghai Changzheng Hospital

    lead OTHER

Principal Investigators

  • Huji Xu, Ph.D, MD · Shanghai Changzheng Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2024-04-20
Primary Completion
2025-04-15
Completion
2026-04-15

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT06373081 on ClinicalTrials.gov