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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03907527 | Modified Immune Cells (Autologous CAR T Cells) in Treating Patients with Advanced, Recurrent Platinum Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer | PHASE1 | ACTIVE NOT_RECRUITING | 71 | — | — | Apr 30, 2019 | Nov 15, 2028 | Nov 8, 2024 | 2 | United States |
Toxicity grading will be evaluated according to the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events version 5.0 and monitoring of adverse events
Will be determined by a 3 X 3 dose escalation study for both intraperitoneal infusion and intravenous infusion of the trial.
| Arm | Type | Description |
|---|---|---|
| Treatment (PRGN-3005 UltraCAR-T cells) IP Administration | EXPERIMENTAL | Patients receive autologous PRGN-3005 UltraCAR-T cells via IP administration with or without lymphodepleting chemotherapy. |
| Treatment (PRGN-3005 UltraCAR-T cells) IV Administration | EXPERIMENTAL | Patients receive autologous PRGN-3005 UltraCAR-T cells via IV administration with or without lymphodepleting chemotherapy. |
| Name | Type | Description |
|---|---|---|
| PRGN-3005 UltraCAR-T cells | BIOLOGICAL | Given IP |
Inclusion Criteria: * Women with recurrent, advanced, platinum resistant ovarian, fallopian tube, and primary peritoneal cancer that have progressed after receiving standard of care therapies or are not eligible to receive available therapies with known clinical benefit will be eligible for the stu...