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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07015983 | A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE) | PHASE2 | RECRUITING | 89 | — | — | Jul 14, 2025 | Jun 15, 2032 | May 8, 2026 | 93 | United States, Argentina +14 |
| Arm | Type | Description |
|---|---|---|
| Administration of CC-97540 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| CC-97540 | DRUG | Specified dose on specified days |
| Fludarabine | DRUG | Specified dose on specified days |
| Cyclophosphamide | DRUG | Specified dose on specified days |
Inclusion Criteria: * Participants must meet EULAR/ACR 2019 criteria for SLE. * Participants must have an inadequate response to appropriate doses of glucocorticoids and ≥ 2 immunosuppressant therapies, used for at least 3 months. * Participants must have active disease when signing ICF. Exclusion...