Actively Recruiting

Early Phase 1
Age: 18Years - 65Years
All Genders
NCT06653556

A Study of LCAR-AIO in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus

Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2025-01-10

34

Participants Needed

1

Research Sites

246 weeks

Total Duration

On this page

Sponsors

U

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Lead Sponsor

N

Nanjing Legend Biotech Co.

Collaborating Sponsor

AI-Summary

What this Trial Is About

This is a prospective, single-arm, open-label, dose-exploration and expansion clinical study of LCAR-AIO in adult subjects with relapsed/refractory systemic lupus erythematosus.

CONDITIONS

Official Title

A Study of LCAR-AIO in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Subjects voluntarily participate in clinical research
  • Age 18-65 years
  • Diagnosed with systemic lupus erythematosus (SLE) at least 6 months before screening
  • Positive antinuclear antibody, anti-dsDNA antibody, or anti-Sm antibody at screening
  • Relapsed or refractory SLE condition
  • Adequate organ function at screening
  • Clinical laboratory values meet criteria at screening
Not Eligible

You will not qualify if you...

  • Active infections such as hepatitis and tuberculosis
  • Other autoimmune diseases
  • Serious underlying diseases such as tumors or uncontrolled diabetes
  • Female subjects who are pregnant, breastfeeding, or planning pregnancy during the study or within 1 year after treatment
  • Participation in other clinical trials within an unspecified recent period

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Wuhan Union Hospital

Wuhan, Hubei, China

Actively Recruiting

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Research Team

Q

Qiubai Li, Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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