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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06294236 | Study Evaluating SC291 in Subjects With Severe r/r B-cell Mediated Autoimmune Diseases (GLEAM) | PHASE1 | ACTIVE NOT_RECRUITING | 7 | — | — | Apr 29, 2024 | Mar 1, 2028 | Nov 25, 2025 | 5 | United States |
Safety and Tolerability: Proportion of subjects experiencing adverse events and dose-limiting toxicities
| Arm | Type | Description |
|---|---|---|
| LN Cohort | EXPERIMENTAL | SC291 with lymphodepleting therapy |
| ERL Cohort | EXPERIMENTAL | SC291 with lymphodepleting therapy |
| AAV Cohort | EXPERIMENTAL | SC291 with lymphodepleting therapy |
| Name | Type | Description |
|---|---|---|
| SC291 | BIOLOGICAL | SC291 is an allogeneic CAR T cell therapy |
Inclusion Criteria: 1. Age ≥18 and ≤75 2. For LN cohort: * Diagnosis of SLE based on the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) * Biopsy-proven LN class III or IV, according to 2018 Revised International Society of Nephrology/Renal Pathology So...