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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06934447 | Study of BCMA/CD70 CAR-T Therapy for Refractory cSLE | PHASE1 | RECRUITING | 18 | — | — | Apr 25, 2025 | Apr 1, 2028 | Apr 25, 2025 | 1 | China |
Incidence and severity of AEs and SAEs,including changes in laboratory values, Electrocardiograph(ECG) and vital signs assessed by CommonTerminology Criteria for Adverse Events (CTCAE) v5.0.
Number of patients with SRI-4 response:including SLEDAI-2K ≥ 4-Point improvement, PGA with no worsening (\&amp;amp;lt;0.3-point increase), BILAG 2004 with no new A domain score and no more than 1 new B domain scores. Number of patients with DORIS: including SLEDAI-2K = 0 and a Physician's Global Assessment (PGA) \< 0.5, irrespective of serology, with permitted use of antimalarials, low-dose glucocorticoids (GCs; prednisolone ≤ 5 mg/day), and/or stable immunosuppressives and biologics.
| Arm | Type | Description |
|---|---|---|
| CAR-T treatment group | EXPERIMENTAL | This trial was designed as an open, single-arm, multicenter, dose-increasing trial. |
| Name | Type | Description |
|---|---|---|
| anti-BCMA/CD70-CAR-T cells | BIOLOGICAL | Three dose groups (0.3×105/kg, 1×105/kg, 3×105/kg) were set up, starting from the low dose group climbing to explore the safe and effective dose. |
Inclusion Criteria: 1. Age:≥5 years old; 2. Diagnosed with SLE according to the 2019 EULAR/ACR SLE classification criteria；Still in moderate to severe disease activity despite ≥3M of high dose glucocorticoids(prednisone≥1mg/kg/d or other equivalent amount of other steriod ), hydroxychloroquine and ...