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Also known as PRGN-3005 UltraCAR-T cells
PRGN-3005 · 1 trial · 34 indications
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...
PRGN-3005 is an investigational cell therapy being developed by Precigen, Inc. for platinum-resistant fallopian tube carcinoma, along with platinum-resistant ovarian and primary peritoneal cancers. It is an autologous CAR T cell product, meaning a patient's own modified immune cells are used, and it is designed to target the ROR1 protein. It remains in Phase 1 clinical development.
PRGN-3005 is being studied for platinum-resistant fallopian tube carcinoma, a form of the disease that has progressed after platinum-based chemotherapy. The same Phase 1 trial also enrolls patients with platinum-resistant ovarian carcinoma and platinum-resistant primary peritoneal carcinoma, including recurrent, refractory, and advanced stage III or stage IV disease.
PRGN-3005 targets ROR1, a cell surface protein. The therapy is an autologous CAR T cell product in which a patient's own immune cells are modified to recognize ROR1, directing those cells against ROR1-expressing tumors. ROR1 is the molecular target of the program, and the study enrolls a biomarker-selected patient population.
PRGN-3005 is being developed by Precigen, Inc., which trades on the Nasdaq under the ticker PGEN. Precigen is the sponsor of the clinical program evaluating the therapy in platinum-resistant gynecologic and peritoneal cancers.
PRGN-3005 is in Phase 1 clinical development. It is an investigational therapy and has not been approved by the FDA. The program has one trial, which is currently active and no longer recruiting participants, and no completed trials.
PRGN-3005 is being evaluated in the Phase 1 trial NCT03907527, titled a study of modified immune cells (autologous CAR T cells) in treating patients with advanced, recurrent platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer. The trial is active but not recruiting, is controlled, is not randomized or double blinded, and has an estimated enrollment of 71 patients at sites in the United States.
Yes. PRGN-3005 UltraCAR-T cells is another name for PRGN-3005, the autologous CAR T cell therapy developed by Precigen, Inc. that targets ROR1. Searches using either name refer to the same Phase 1 investigational program in platinum-resistant fallopian tube, ovarian, and primary peritoneal cancers.