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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06375993 | A Phase 1 Study of Prulacabtagene Leucel (Prula-cel, Formerly ADI-001) in Autoimmune Disease | PHASE1 | ENROLLING BY_INVITATION | 180 | — | — | Nov 10, 2024 | Dec 1, 2027 | Mar 19, 2026 | 2 | United States |
This primary endpoint will be used to determine the Maximum Tolerated Dose (MTD) or Maximum Assessed dose (MAD)
This primary endpoint will be used to determine the MTD/MAD of ADI-001
| Arm | Type | Description |
|---|---|---|
| ADI-001 Dose Escalation | EXPERIMENTAL | ADI-001 is administered via infusion with ascending dose levels as a single dose to determine the maximum tolerated dose (MTD) or maximum assessed dose (MAD) of ADI-001. |
| ADI-001 Dose Extension | EXPERIMENTAL | After dose level has been declared safe, additional patients can be enrolled at the declared safe dose to further investigate the safety profile of ADI-001. Dose extension patients will not contribute to the determination of MTD/MAD and DLT evaluation. |
| ADI-001 Dose Expansion | EXPERIMENTAL | Dose Expansion ADI-001 is administered via infusion at the MTD/MAD to confirm recommended phase 2 dose (Part 2). |
| Name | Type | Description |
|---|---|---|
| ADI-001 | DRUG | Anti-CD20 CAR-T |
| Fludarabine | DRUG | Chemotherapy for Lymphodepletion |
| Cyclophosphamide | DRUG | Chemotherapy for Lymphodepletion |
Inclusion Criteria: For Cohort 1: Subjects with LN: * Clinical diagnosis of systemic lupus erythematosus (SLE) per 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria (Aringer 2019). * Have unequivocally positive anti-nuclear antibody (ANA...