RecruitingEarly Phase 1

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

China34 participantsStarted 2025-01-08

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Exclusion criteria

✕. Active infections such as hepatitis and tuberculosis.
✕. Other autoimmune diseases.
✕. Serious underlying diseases such as tumor, uncontrolled diabetes.
✕. 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.
✕. Participated in other clinical trials within

What they're measuring

Incidence, severity, and type of treatment-emergent adverse events (TEAEs)

Timeframe: Minimum 104 Weeks after LCAR-AIO infusion (Day 1)

Incidence of dose-limiting toxicity (DLT)

Timeframe: 30 days after LCAR-AIO infusion (Day 1)

Pharmacokinetics in peripheral blood

Timeframe: Minimum 104 Weeks after LCAR-AIO infusion (Day 1)

Recommended Phase 2 Dose (RP2D) regimen finding

Timeframe: Minimum 104 Weeks after LCAR-AIO infusion (Day 1)

Trial details

NCT IDNCT06653556

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

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09-30

Contact for this trial

Qiubai Li, Professor

85726808 qiubaili@hust.edu.cn

View on ClinicalTrials.gov More Systemic Lupus Erythematosus (SLE) trials