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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06581198 | A Study of Rapcabtagene Autoleucel in Active, Refractory Systemic Lupus Erythematosus (SLE) or Lupus Nephritis (LN) Patients (AUTOGRAPH - SLE/LN) | PHASE2 | RECRUITING | 179 | — | — | Sep 4, 2024 | Feb 6, 2032 | Jun 3, 2026 | 101 | United States, Australia +21 |
Defined as: Meeting the criteria of the Definition Of Remission In Systemic Lupus Erythematosus (DORIS) or Achieving complete renal response (CRR)
| Arm | Type | Description |
|---|---|---|
| rapcabtagene autoleucel | EXPERIMENTAL | rapcabtagene autoleucel |
| Name | Type | Description |
|---|---|---|
| rapcabtagene autoleucel | BIOLOGICAL | single infusion of rapcabtagene autoleucel |
Key Inclusion Criteria: * Men and women with SLE, aged \>= 18 years and =\< 75 years at screening, fulfilling the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE at screening. * Participant must be positive for at least one of t...