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Immunotherapy for Peritoneal Carcinomatosis (IPC) - A Phase I Study of the Safety and Efficacy of Anti-CEA CAR-T Cell Intraperitoneal Infusions for Treatment of CEA-Expressing Adenocarcinoma Peritoneal Metastases or Malignant Ascites
This is an open-label, dose-escalation, phase I trial of the safety and efficacy of anti-CEA intraperitoneal CAR-T infusions for treatment in patients with CEA-expressing adenocarcinoma peritoneal metastases or malignant ascites.
Details
| Lead sponsor | Sorrento Therapeutics, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | WITHDRAWN |
| Start date | 2018-09-13 |
| Completion | 2021-03 |
Conditions
- Peritoneal Carcinomatosis
- Peritoneal Metastases
- Colorectal Cancer
- Gastric Cancer
- Breast Cancer
- Pancreas Cancer
- Carcinoembryonic Antigen
Interventions
- anti-CEA CAR-T cells
Primary outcomes
- Safety of Intraperitoneal CAR-T Cell Infusions as Measured by Number of Participants with Adverse Events — 16 weeks
To determine the safety and maximum tolerated dose (MTD) following intraperitoneal infusion(s) of anti-CEA CAR-T cells for inoperable CEA+ peritoneal metastases or malignant ascites.
Countries
United States