WithdrawnEarly Phase 1

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

Stopped: Discontinue further development of LCAR-AIO program

China0Started 2025-06-17

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 autoimmune diseases.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Subjects voluntarily participate in clinical research.
✓. Age 18-65 years.
✓. Adequate organ function at screening.
✓. Clinical laboratory values meet criteria at screening.

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 4 weeks.

What they're measuring

Change in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) scores from baseline up to 104 weeks

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

Change in Birmingham vasculitis activity score (BVAS) from baseline up to 104 weeks

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

Change in modified Rodnan skin score (mRSS) from baseline up to 104 weeks

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

Change in manual muscle testing (MMT-8) score from baseline up to 104 weeks

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

Change in Physician global assessment (PGA) scores from baseline up to 104 weeks

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

Changes from baseline in immunological markers and Immunogenicity (anti-drug antibody) from baseline up to 104 weeks

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

Trial details

NCT IDNCT06866080

SponsorNanjing Legend Biotech Co.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-06-17

View on ClinicalTrials.gov More Relapsed/Refractory Autoimmune Diseases trials

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Subjects voluntarily participate in clinical research.
✓. Age 18-65 years.
✓. Adequate organ function at screening.
✓. Clinical laboratory values meet criteria at screening.

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 4 weeks.