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The Safety and Efficacy of Anti-CD19 CAR-T Cells in Patients With Relapsed/Refractory Autoimmune Diseases

NCT06420154 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2024-05-17

No results posted yet for this study

Summary

This is an investigator-initiated trial to evaluate the safety and efficacy of anti- CD19-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-CAR-T cells

The subjects received infusions of anti-CD19 CAR-T cells following completion of lymphodepleting preconditioning chemotherapy. Dosage：1×10\^5 cells/Kg; 3×10\^5 cells/Kg; 1×10\^6 cells/Kg frequency：single infusion

Sponsors & Collaborators

  • Shanghai First Song Therapeutics Co., Ltd

    collaborator INDUSTRY

  • First Affiliated Hospital of Wenzhou Medical University

    lead OTHER

Principal Investigators

  • LI Sun, Master's · First Affiliated Hospital of Wenzhou Medical University

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
2024-05-27
Primary Completion
2027-05-27
Completion
2027-05-27

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 NCT06420154 on ClinicalTrials.gov