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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06686524 | Clinical Study of CD19 Targeted Universal Chimeric Antigen Receptor T Lymphocytes (UCAR-T) for the Treatment of Refractory Juvenile Dermatomyositis (RJDM) | PHASE1 | RECRUITING | 18 | — | — | Nov 11, 2024 | Nov 10, 2027 | Nov 13, 2024 | 1 | China |
The incidence of adverse events after CAR-T cell infusion was assessed by CTCAE, version 5.0.
The total improvement score between 0-100 also corresponds to the degree of improvement, with higher improvement scores indicating greater improvement.
Including musculoskeletal system score and skin mucosal score, with a total score of 20 points. The higher the score, the higher the disease activity
The total score is 52 points, the lower the score, the weaker the muscle strength and the more severe the disease.
| Arm | Type | Description |
|---|---|---|
| Anti-CD19 UCAR-T cells | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Anti-CD19 UCAR-T cells | DRUG | A single infusion of CD19 UCAR-T cells will be administered intravenously after lymphodepletion chemotherapy. |
Inclusion Criteria: * (1) Age ≥ 5 years old; * (2) Diagnosis of juvenile dermatomyositis (JDM) according to Bohan and Peter criteria; * (3) Meeting the classification criteria for RJDM, and meeting condition ① and any one of ② to ⑤ conditions: * Intolerance or inadequate response to glucocortico...