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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05057715 | huCART-meso + VCN-01 in Pancreatic and Ovarian Cancer | PHASE1 | ACTIVE NOT_RECRUITING | 13 | — | — | Mar 2, 2022 | Sep 1, 2038 | Jun 25, 2025 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | ACTIVE_COMPARATOR | Single dose of 3.3x10(12) vp of VCN-01 on Day 0, followed by a single dose of 5x10(7) of huCART-meso cells on Day 14. |
| Cohort 2 | ACTIVE_COMPARATOR | Single dose of 1x10(13) vp of VCN-01 on Day 0, followed by a single dose of 5x10(7) of huCART-meso cells on Day 14. |
| Cohort -1 | ACTIVE_COMPARATOR | In the event that 2 DLTs occur in Cohort 1, then enrollment in Cohort 1 will be stopped and Cohort -1 will be opened for evaluation. Enrolled subjects will receive a single dose of huCART-meso cells on Day 0 followed by a single dose of 3.3x10(12) vp of VCN-01 on Day 14. |
| Name | Type | Description |
|---|---|---|
| VCN-01 | BIOLOGICAL | Intravenous administration of VCN-01 |
| huCART-meso Cells | BIOLOGICAL | Intravenous administration of huCART-meso cells |
Inclusion Criteria: 1. Patients with one of the following diagnoses: 1. Histologically confirmed unresectable or metastatic pancreatic adenocarcinoma; OR 2. Persistent or recurrent serous epithelial ovarian cancer 2. Progression or intolerance to at least one prior standard of care chemother...