A Study of LCAR-AIO in Subjects With Relapsed/Refractory Autoimmune Diseases

Last updated: July 2, 2025
Sponsor: Nanjing Legend Biotech Co.
Overall Status: Trial Not Available

Phase

1

Condition

Connective Tissue Diseases

Collagen Vascular Diseases

Treatment

LCAR-AIO T cells

Clinical Study ID

NCT06866080
LB2305-0002
  • Ages 18-65
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subjects voluntarily participate in clinical research.

  2. Age 18-65 years.

  3. Adequate organ function at screening.

  4. Clinical laboratory values meet criteria at screening.

SLE:

  • Have been diagnosed of SLE at least 6 months before screening.

  • At screening, antinuclear antibody, and/or anti-dsDNA antibody, and/or anti-Smithantibody should be positive.

  • Fulfill relapsed/refractory SLE conditions.

AAV:

  • Have been diagnosed of AAV before screening.

  • Positive test for anti-PR3 or anti-MPO antibodies at screening.

  • Fulfill relapsed/refractory AAV conditions.

SSc:

  • Have been diagnosed of SSc before screening.

  • At screening, mRSS is higher than 10.

  • Fulfill relapsed/refractory SSc conditions.

IIM:

  • Have been diagnosed of IIM before screening.

  • Positive test for myositis-associated antibodies or myositis-specific antibodies atscreening.

  • Fulfill relapsed/refractory IIM conditions.

Exclusion

Exclusion Criteria:

  1. Active infections such as hepatitis and tuberculosis.

  2. Other autoimmune diseases.

  3. Serious underlying diseases such as tumor, uncontrolled diabetes.

  4. Female subjects who were pregnant, breastfeeding, or planning to become pregnantwhile participating in this study or within 1 year of receiving LCAR-AIO treatment.

  5. Participated in other clinical trials within 4 weeks.

Study Design

Treatment Group(s): 1
Primary Treatment: LCAR-AIO T cells
Phase: 1
Study Start date:
June 17, 2025
Estimated Completion Date:
June 17, 2025

Study Description

This is a prospective, single-arm, open-label exploratory clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy profiles of LCAR-AIO, a chimeric antigen receptor (CAR) -T cell therapy in subjects with relapsed/refractory autoimmune diseases. Patients who meet the eligibility criteria will receive LCAR-AIO infusion. The study will include the following sequential stages: screening, apheresis, pre-treatment (cell product preparation: lymphodepleting chemotherapy), treatment (LCAR AIO infusion) and follow-up.

Connect with a study center

  • The First Affiliated Hospital of USTC (anhui provincial hospital)

    Hefei,
    China

    Site Not Available

  • Jiangsu Province Hospital

    Nanjing,
    China

    Site Not Available

  • The 1st Affiliated Hospital of WHU

    Wenzhou,
    China

    Site Not Available

  • The Affiliated Hospital of XUZHOU Medical University

    Xuzhou,
    China

    Site Not Available

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