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

RECRUITINGEarly 1Sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Actively Recruiting
PhaseEarly 1
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology
Started2025-01-08
Est. completion2027-09-30
Eligibility
Age18 Years – 65 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06653556

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

Age: 18 Years – 65 YearsHealthy volunteers accepted
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-Sm antibody should be positive.
5. Fulfill relapsed/refractory SLE conditions.
6. Adequate organ function at screening.
7. Clinical laboratory values meet criteria at screening.

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 pregnant while participating in this study or within 1 year of receiving LCAR-AIO treatment.
5. Participated in other clinical trials within

Conditions2

LupusSystemic Lupus Erythematosus (SLE)

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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