Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Wenzhou Medical University Affiliated Ophthalmology Hospital | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
This is an open label, Multi-center,dose-escalation study in up to 18 participants with refractory NMOSD. This study aims to evaluate the safety and efficacy of universal CAR-T Cells targeting BCMA in the Treatment of refractory NMOSD.
This is a multi-center, single-arm, open-label clinical study, and the sample size is set to 12-18 subjects. Based on the "3 + 3" dose escalation design principle, subjects will be divided into 3 groups from low dose to high dose in sequence (Group A; Group B; Group C).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BCMA CART Group | Experimental | 1.0-4.0×10^6 CAR- Tcells/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Universal BCMA-CD19 CART | Drug | 1.0-4.0×10^6 CAR-T cells/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| DLT | The number and severity of dose-limiting toxicity (DLT) events | Within28 Days After BRL-302 Infusion |
| AEs | The total number, incidence, and severity of AEs | Up to 12 Months After BRL-302 Infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Annualized relapse rate (ARR) | Number of NMOSD relapses in subjects after cell infusion divided by observation time (years) | 1,3,6,12 month after BRL-302 infusion |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaohui Wang, PhD | Contact | 18701533866 | xiaoxiao512006@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaohui Wang, PhD | Wenzhou Medical University Affiliated Ophthalmology Hospital | Study Chair |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
Not provided
Not provided
Total target count of CD3+CAR+ viable cells of 1E6/kg 、2E6/kg and 4E6/kg
Not provided
Not provided
Not provided
Not provided