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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07184450 | Clinical Study of BCMA/CD70-targeted CAR-T Therapy for Refractory Pediatric Rheumatic Diseases | PHASE1 | RECRUITING | 11 | — | — | Sep 1, 2025 | Sep 30, 2028 | Sep 19, 2025 | 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.
The proportion of subjects who achieved the minimal, moderate, and major clinical response of the Total Improvement Score (TIS) within 6 months after reinfusion.
The proportion of subjects who achieved minimal disease activity, inactive disease and remission within 6 months.
The proportion of subjects who achieved Ped ACR 30/50/70/90/100 within 6 months.
The changes from baseline in the modified Rodnan skin score (mRSS) within 6 months.
The changes from baseline in modified disease activity index (MDAI) within 6 months.
The changes from baseline in EUSTAR activity index within 6 months.
The changes from baseline in Composite Response Index (CRISS) within 6 months.
The proportion of subjects who achieved minimal disease activity, inactive disease and remission within 6 months.
The proportion of subjects who achieved the STAR response rate within 6 months.
The changes from baseline in ESSDAI within 6 months.
The changes from baseline in clinESSDAI within 6 months.
The changes from baseline in ESSPRI within 6 months.
| Arm | Type | Description |
|---|---|---|
| BCMA/CD70-targeted CAR-T | EXPERIMENTAL | The experiment was divided into two phases: dose exploration (Part A) and dose extension (Part B).In Part A, three dose groups (0.3×10\^5/kg, 1×10\^5/kg, 3×10\^5/kg) are set up, starting from the low dose group to explore the safe and effective dose.Upon the completion of Part A, 1 optimal dose is selected to enter into the Part B stage. The group will then be enrolled in 1\~2 cases to continue to validate the safety and efficacy.The enrollment of 4-11 patients is expected in the each indication of the trial. |
| Name | Type | Description |
|---|---|---|
| BCMA/CD70-targetd CAR-T | BIOLOGICAL | Subjects underwent lymphocytetion cheotherapy and then received a single intravenous cell infusion |
Inclusion Criteria: * Age ≥5 years old. * To meet the diagnostic criteria of refractory B-cell-related pediatric rheumatic diseases, including but not limited to juvenile dermatomyositis, polyarticular juvenile idiopathic arthritis, systemic sclerosis, and primary Sjogren's syndrome. 1. Diagnose...