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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06569472 | Clinical Trial of CD19-targeted CAR-T Therapy for Refractory Juvenile Dermatomyositis | PHASE1 | RECRUITING | 10 | — | — | Jul 2, 2024 | Jul 31, 2028 | Aug 26, 2024 | 1 | China |
The incidence of adverse events after CAR-T cell infusion was assessed by the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 5.0).including the type, frequency and severity of adverse events
Disease improvement rate: The number of subjects who achieved disease improvement as a percentage of all subjects who received transfusions.
DOR will be assessed from the first assessment of remission to the first assessment of recurrence or progression of the disease or death from any cause
| Arm | Type | Description |
|---|---|---|
| CD19-targeted CAR-T | EXPERIMENTAL | The experiment was divided into two phases: dose exploration (Part A) and dose extension (Part B). |
| Name | Type | Description |
|---|---|---|
| CD19-targetd CAR-T | BIOLOGICAL | Subjects underwent lymphocyte clearance chemotherapy and then received a single intravenous cell infusion |
Inclusion Criteria: 1. Age: ≥5 years and \<17 years old 2. To meet the diagnostic criteria of JDM, four or five of the following criteria must be met:① symmetrical proximal muscle weakness; ②Characteristic skin changes, including positive dermatitis (purplish red rash on upper eyelid with periorbit...