Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06869278 | A Study of LCAR-AIO CAR-T Cells for Treating Relapsed/Refractory Neurological Autoimmune Diseases | PHASE1 | RECRUITING | 37 | — | — | Jun 17, 2025 | Dec 31, 2029 | Jun 11, 2025 | 3 | China |
An adverse event refers to any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product (investigational or non-investigational), which does not necessarily have a causal relationship with the treatment.
DLTs are severe adverse events refers to any untoward medical occurred in a subject participated in a clinical investigation, which have a causal relationship with the treatment and will limit the dose escalation.
Venous blood samples will be collected for measurement of CAR-T positive cellular concentration.
RP2D established through dose exploratory.
Transgene Levels of LCAR-AIO CAR-T Cells using sensitive assay methods will be assessed
| Arm | Type | Description |
|---|---|---|
| LCAR-AIO T Cells | EXPERIMENTAL | Chimeric antigen receptor T cells (LCAR-AIO) Each subject will be given a single-dose LCAR-AIO cells infusion at each dose level |
| Name | Type | Description |
|---|---|---|
| LCAR-AIO T cells | BIOLOGICAL | Before treatment with LCAR-AIO T cells, subjects will receive a conditioning regimen. |
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...