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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04503278 | A Clinical Study of the Safety and Effectiveness of an Investigational Cell Therapy Given With and Without an Investigational RNA-based Vaccine in Patients With Organ Tumors | PHASE1 | RECRUITING | 214 | — | — | Sep 16, 2020 | Aug 1, 2041 | Apr 17, 2026 | 12 | Australia, Germany +2 |
| Arm | Type | Description |
|---|---|---|
| Part 1 - CLDN6 CAR-T | EXPERIMENTAL | Dose escalation in lymphodepleted patients until the MTD and/or RP2D. |
| Part 2 Vaccine-modulated - CLDN6 uRNA-LPX/CLDN6 modRNA-LPX | EXPERIMENTAL | Dose escalation until the MTD and/or RP2D. |
| Name | Type | Description |
|---|---|---|
| CLDN6 CAR-T | BIOLOGICAL | administered as an intravenous (i.v.) infusion. |
| CLDN6 uRNA-LPX/CLDN6 modRNA-LPX | BIOLOGICAL | administered as an i.v. injection at protocol-specified intervals. |
Inclusion Criteria: * Each patient enrolled in the trial must have CLDN6-positive tumor regardless of tumor histology defined as ≥ 50% of tumor cells expressing CLDN6 protein at an intensity of ≥2+ using a semi-quantitative immunohistochemistry assay in a central laboratory for specific detection o...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab, V503, GARDASIL |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| AstraZeneca PLC | AZN | 1 | — | Trastuzumab deruxtecan |