Dual Administration Of Intraperitoneal And Intravenous TROP2-Directed CAR-NK With TGF-Beta Recept… (NCT07411599) | Clinical Trial Compass
RecruitingPhase 1/2
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")
United States28 participantsStarted 2026-04-20
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 systemic cytotoxic chemotherapy at the time of their diagnostic laparoscopy (DL)/IP catheter placement or 6 weeks if the chemotherapy regimen included Bevacizumab. Participants must be at least 4 weeks from their last dose of systemic cytotoxic chemotherapy at the time of their lymphodepleting (LD) chemotherapy.
* Subjects must be willing to undergo DL and IP catheter placement along with scheduled peritoneal fluid/peripheral blood draws and biopsies.
* Subjects must have adequate organ function as defined in the following table. Specimens must be collected within 10 days prior to the start of study treatment.
* Participant s must have histologically confirmed microsatellite stable (MSS) CRC-related PM that is not amenable to curative resection (participant determined not to be a candidate for CRS +/- HIPEC by surgical oncologist with expertise in peritoneal surface malignancies) and for whi…
What they're measuring
1
Safety and adverse events (AEs
Timeframe: Through study completion; an average of 1 year