NCT07411599

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")

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Colorectal Cancer
• Peritoneal Metastases
• Carcinomatosis

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	Given by IV
DRUG	Fludarabine	Given by IV
DRUG	Cetuximab	Given by IV
DRUG	NK Cells	Given by IV and IP

Timeline

• Start date: 2026-07-29
• Primary completion: 2028-11-15
• Completion: 2030-11-15
• First posted: 2026-02-17
• Last updated: 2026-03-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study