RecruitingPhase 1

A Study of LCAR-AIO CAR-T Cells for Treating Relapsed/Refractory Neurological Autoimmune Diseases

China37 participantsStarted 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 neurological autoimmune diseases.

Who can participate

Age range18 Years – 70 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 18-70 years.
✓. Adequate organ function at screening.
✓. Clinical laboratory values meet criteria at screening visit.
✓. Indications include:
✓. Have been diagnosed of MS at least 6 months before screening.
✓. Fulfill relapsed/refractory MS conditions.
✓. Have been diagnosed of NMOSD/MOGAD at least 6 months before screening.

Exclusion criteria

✕. Active infections such as hepatitis and tuberculosis.
✕. Other autoimmune diseases.
✕. Serious underlying diseases such as tumor, uncontrolled diabetes and clinically significant cardiovascular disease.
✕. 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.

What they're measuring

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

Timeframe: Baseline to 104 Weeks after last subject infusion

Incidence of dose-limiting toxicity (DLT)

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

Chimeric Antigen Receptor T (CAR-T) Positive Cell Concentration

Timeframe: Baseline to 104 Weeks after last subject infusion

Recommended Phase 2 Dose (RP2D) regimen finding

Timeframe: Baseline to 104 Weeks after last subject infusion

Transgene Levels of LCAR-AIO CAR-T Cells

Timeframe: Baseline to 104 Weeks after last subject infusion

Trial details

NCT IDNCT06869278

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

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-30

Contact for this trial

Qiubai li

18221636229 Tingyu.Zhang@legendbiotech.cn

View on ClinicalTrials.gov More Multiple Sclerosis (MS) trials

Who can participate

Age range18 Years – 70 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 18-70 years.
✓. Adequate organ function at screening.
✓. Clinical laboratory values meet criteria at screening visit.
✓. Indications include:
✓. Have been diagnosed of MS at least 6 months before screening.
✓. Fulfill relapsed/refractory MS conditions.
✓. Have been diagnosed of NMOSD/MOGAD at least 6 months before screening.

Exclusion criteria

✕. Active infections such as hepatitis and tuberculosis.
✕. Other autoimmune diseases.
✕. Serious underlying diseases such as tumor, uncontrolled diabetes and clinically significant cardiovascular disease.
✕. 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.

What they're measuring

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

Timeframe: Baseline to 104 Weeks after last subject infusion

Incidence of dose-limiting toxicity (DLT)

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

Chimeric Antigen Receptor T (CAR-T) Positive Cell Concentration

Timeframe: Baseline to 104 Weeks after last subject infusion

Recommended Phase 2 Dose (RP2D) regimen finding

Timeframe: Baseline to 104 Weeks after last subject infusion

Transgene Levels of LCAR-AIO CAR-T Cells

Timeframe: Baseline to 104 Weeks after last subject infusion