Dual Administration Of Intraperitoneal And Intravenous TROP2-Directed CAR-NK With TGF-Beta Receptor 2 (TGFBR2) Knock Out (KO) Therapy For Colorectal Cancer-Related Peritoneal Carcinomatosis: A Phase 1/2 Trial ("Chip-CRC Trial")
M.D. Anderson Cancer Center
Summary
To find the highest dose of NK cells that can be given by vein and intraperitoneally (given directly into the abdominal cavity) in combination with cetuximab to patients with colorectal cancer that has spread to the peritoneum.
Description
Primary Objective and Endpoints Objective: Determine the safety, and Maximum Tolerated Dose (MTD), Recommended Phase 2 Dose (RP2D), schedule of iterative delivery of dual administration of IP/IV TROP2 CAR/IL-15 TGFBR2 KO NK cells Cell Therapy + IV Cetuximab
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Eligibility Criteria * Subjects must be 18 years or older. Because no dosing or adverse event data are currently available on the use of IP/IV TROP2 CAR/IL-15 TGFBR2 KO NK Cell Therapy + Cetuximab in participants 3 liver metastases, \>5 lung metastases, or \>8 metastases combined between all extraperitoneal sites will not be included even in the setting of measurable peritoneal disease. If a participant has peritoneal-predominant disease with ≤ 8 total extraperitoneal metastases, they may be included at the discretion of the PI. * Subjects must be at least 4 weeks from their last dose of syst…
Interventions
- DrugCyclophosphamide
Given by IV
- DrugFludarabine
Given by IV
- DrugCetuximab
Given by IV
- DrugNK Cells
Given by IV and IP
Location
- MD Anderson Cancer CenterHouston, Texas