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

Last updated: January 8, 2025
Sponsor: Wuhan Union Hospital, China
Overall Status: Active - Recruiting

Phase

1

Condition

Cutaneous Lupus Erythematosus

Systemic Lupus Erythematosus

Lupus

Treatment

LCAR-AIO T cells

Clinical Study ID

NCT06653556
LB2305-0001
  • 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 systemic lupus erythematosus.

Eligibility Criteria

Inclusion

  1. Subjects voluntarily participate in clinical research.

  2. Age 18-65 years.

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

  4. At screening, antinuclear antibody, and/or anti-dsDNA antibody, and/or anti-Smantibody should be positive.

  5. Fulfill relapsed/refractory SLE conditions.

  6. Adequate organ function at screening.

  7. Clinical laboratory values meet criteria at screening.

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

Study Design

Total Participants: 34
Treatment Group(s): 1
Primary Treatment: LCAR-AIO T cells
Phase: 1
Study Start date:
January 08, 2025
Estimated Completion Date:
September 30, 2029

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 systemic lupus erythematosus. 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

  • Wuhan Union Hospital

    Wuhan, Hubei
    China

    Active - Recruiting

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