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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07403097 | Study of CD19 CAR-T Therapy for Refractory SLE | PHASE1 | RECRUITING | 18 | — | — | Feb 1, 2026 | Dec 1, 2028 | Feb 11, 2026 | 1 | China |
Types, frequency and severity of adverse events.
Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) ranges from 0 to 105 points. The higher the score, the higher the disease activity.
Physician Global Assessment(PGA) is a continuous visual analogue scale with 0, 1, 2, and 3 scores. "0" indicates no disease activity and "3" indicates the most severe disease activity.
British Isles Lupus Assessment Group Index 2004(BILAG-2004) consists of 8 systems, each of which is graded as A, B, C and D. "A" indicates that the condition is highly active and requires active treatment. "B" indicates that the condition is active and requires close monitoring or symptomatic treatment. "C" indicates a stable condition. "D" indicates that the system is uninvolved.
The definition of SRI-4 response: SLEDAI-2K ≥ 4 points improvement; PGA \<0.3 points increase; BILAG 2004 with no new A grade score and no more than 1 new B grade score.
The definition of LLDAS: SLEDAI-2K ≤ 4 points and no disease activity in major organs (kidney, central nervous system, heart and lung), and no vasculitis or fever; no new disease activity symptoms compared with previous disease assessments; PGA ≤ 1; serological parameters not required; with the permitted use of low-dose glucocorticoids (prednisolone ≤ 7.5 mg/day), and/or stable immunosuppressives and biologics.
The definition of DORIS: SLEDAI-2K = 0 points; PGA \< 0.5 points; serological parameters not required; with the permitted use of antimalarials, low-dose glucocorticoids (prednisolone ≤ 5 mg/day), and/or stable immunosuppressives and biologics.
| Arm | Type | Description |
|---|---|---|
| PTOC1 | EXPERIMENTAL | This trial was designed as an open, single-arm, single-center, dose-exploration trial. |
| Name | Type | Description |
|---|---|---|
| PTOC1 | BIOLOGICAL | Three dose groups (1.5×10\^5/kg, 5×10\^5/kg,1×10\^6/kg) were set up, starting from the low dose group climbing to explore the safe and effective dose. |
Inclusion Criteria: * Age ≥ 5 years, no gender limitation; * Diagnosed with SLE according to the 2019 EULAR/ACR classification criteria, and still in moderate to severe disease activity despite ≥ 3 months of high dose glucocorticoids(prednisone≥1mg/kg/d or other equivalent amount of other steroid),...