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 range

18 Years – 65 Years

Sex

ALL

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

18 Years – 65 Years

Sex

ALL

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.