TROP2 CAR/IL-15 TGFBR2 KO NK Cells

Primary Objectives: To determine the safety, MTD, and RP2D of TROP2 CAR/IL-15 TGFBR2 KO NK cells delivered intraperitoneally and define the MTD/RP2D. Endpoints 1. Dose-limiting toxicity 2. MTD and RP2D of TROP2 CAR/IL-15 TGFBR2 KO NK cells Secondary Objectives: 1. To estimate median overall survival. 2. To quantify persistence of infused allogeneic donor CAR-transduced CB-derived NK cells in the peripheral blood and peritoneal cavity in the recipient. 3.

To profile and assess the dynamic changes in the peritoneal tumor microenvironment before and after treatment using single-cell transcriptional and immune profiling on peritoneal cells before and after treatment. 4. To compare changes in circulating tumor DNA (ctDNA) with response as determined by the peritoneal carcinomatosis index Endpoints 1. Median overall survival 2. TROP2 CAR/IL-15 TGFBR2 KO NK cells numbers in peripheral blood and peritoneal cavity vs time profile 3.

The goal of this clinical research study is to study the recommended dose of TROP2 CAR/IL-15 TGFBR2 KO NK cells that can be given intraperitoneally (infused directly into the stomach area) to participants with adenocarcinoma of the stomach that has spread to the peritoneum. The safety and effectiveness of this treatment will also be studied.

Registro actualizado en ClinicalTrials.gov →

• Subjects must be 18 years or older. Because no dosing or adverse event data are currently available on the use of CAR NK cells in combination with our standard of care approaches of cytoreductive surgery with intraperitoneal chemotherapy in patients <18 years of age, children are excluded from this study.
• Subjects must be willing and able to provide informed consent.
• Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• A female participant is eligible to participate if at least one of the following conditions applies:
• Not a woman of childbearing potential (WOCBP) as defined in Appendix 1 OR
• A WOCBP who agrees to follow the contraceptive guidelines in Appendix 1 during the treatment period and for at least 3 months after the last dose of study treatment.

Criterios de inclusión tal como figuran en el registro, recortados. La lista completa, con las exclusiones, está en el registro actualizado.