A Study of LCAR-AIO CAR-T Cells for Treating Relapsed/Refractory Neuro
An Open Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LCAR-AIO CAR-T Cells for Treating Relapsed/Refractory Neurological Autoimmune Diseases
What it found
The trial ended early for another reason (see below).
Reason given: Legend discontinues the development of the IMP.
What was tested
Treatment tested
- LCAR-AIO T cells
What it measured
Main measures
Incidence, severity, and type of treatment-emergent adverse events (TEAEs)
Baseline to 104 Weeks after last subject infusion
SafetyIncidence of dose-limiting toxicity (DLT)
30 days after LCAR-AIO infusion (Day 1)
SafetyChimeric Antigen Receptor T (CAR-T) Positive Cell Concentration
Baseline to 104 Weeks after last subject infusion
Recommended Phase 2 Dose (RP2D) regimen finding
Baseline to 104 Weeks after last subject infusion
Transgene Levels of LCAR-AIO CAR-T Cells
Baseline to 104 Weeks after last subject infusion
Other measures (7)
Annua Relapse Rate (ARR)
Baseline to 104 Weeks after last subject infusion
RelapsesChange in Expanded Disability Status Scale (EDSS) scores from baseline up to 104 weeks
Baseline to 104 Weeks after last subject infusion
Disability progressionChanges in Visual Acuity from baseline up to 104 weeks
Baseline to 104 Weeks after last subject infusion
VisionChanges in Visual analogue scale (VAS) pain score from baseline up to 104 weeks
Baseline to 104 Weeks after last subject infusion
PainChanges in MSE proportion from baseline up to 104 weeks
Baseline to 104 Weeks after last subject infusion
Changes in Quantitative Myasthenia Gravis Score (QMGS) from baseline up to 104 weeks
Baseline to 104 Weeks after last subject infusion
Changes in Myasthenia Gravis Activities of Daily Living (MG-ADL) score from baseline up to 104 weeks
Baseline to 104 Weeks after last subject infusion
Who could take part
MS (type not specified) · 18 to 70
Show the full criteria
Inclusion criteria
1. Subjects voluntarily participate in clinical research. 2. Age 18-70 years. 3. Adequate organ function at screening. 4. Clinical laboratory values meet criteria at screening visit. 5. Indications include: MS; 1. Have been diagnosed of MS at least 6 months before screening. 2. Fulfill relapsed/refractory MS conditions. NMOSD/MOGAD: 1. Have been diagnosed of NMOSD/MOGAD at least 6 months before screening. 2. AQP-4 IgG (NMOSD), or MOG-IgG (MOGAD) should be positive by CBA (Cell based transfection immunofluorescence assay). 3. Fulfill relapsed/refractory NMOSD/MOGAD conditions. MG: 1. Have been diagnosed of MG at least 6 months before screening. 2. AChR-IgG or MuSK-IgG should be positive. 3. Fulfill relapsed/refractory NMOSD/MOGAD conditions.
Exclusion criteria
1. Active infections such as hepatitis and tuberculosis. 2. Other autoimmune diseases. 3. Serious underlying diseases such as tumor, uncontrolled diabetes and clinically significant cardiovascular disease. 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
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History
Started
Jun 2025
Main results due
Jun 2025
Finished
Jun 2025