Actively Recruiting
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")
Led by M.D. Anderson Cancer Center · Updated on 2026-04-23
28
Participants Needed
1
Research Sites
238 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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")
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Histologically confirmed microsatellite stable colorectal cancer-related peritoneal metastases not suitable for curative surgery
- Have progressed through at least one line of standard systemic chemotherapy or are intolerant to systemic chemotherapy
- Willing to undergo diagnostic laparoscopy and intraperitoneal catheter placement with scheduled blood and peritoneal fluid collection
- Adequate organ function as defined by study requirements
- At least 4 weeks since last systemic cytotoxic chemotherapy (6 weeks if regimen included Bevacizumab) prior to diagnostic laparoscopy and lymphodepleting chemotherapy
- No more than 3 liver metastases, 5 lung metastases, or 8 total extraperitoneal metastases unless at the discretion of the principal investigator
- New York Heart Association Functional Classification of 2B or better for cardiac function
- Women of childbearing potential and men must agree to use adequate contraception during the study and for 4 months after treatment
- Prior or concurrent malignancies allowed if they do not interfere with study assessment
You will not qualify if you...
- Pregnant, breastfeeding, or planning to conceive during the study and 4 months after last treatment
- Tumors with BRAFV600E mutation
- Received systemic anti-cancer therapy within 4 weeks prior to diagnostic laparoscopy or 6 weeks if it included Bevacizumab
- Have not recovered to Grade 1 or baseline from adverse events of prior therapies
- Prior radiotherapy within 2 weeks before study start, except limited palliative radiation with a 1-week washout
- Received live vaccines within 30 days prior to lymphodepleting chemotherapy
- Currently receiving other investigational agents or devices within 6 weeks prior to study intervention
- Immunodeficiency or recent high-dose steroid or immunosuppressive therapy
- High-volume extra-peritoneal metastases including more than 3 liver metastases, more than 5 lung metastases, CNS metastases, carcinomatous meningitis, or more than 8 total visceral extraperitoneal metastases
- Active autoimmune disease requiring systemic treatment in past 2 months
- History of interstitial lung disease requiring steroids or current pneumonitis
- Serious active infection needing intravenous therapy
- Uncontrolled HIV infection
- Untreated or uncontrolled Hepatitis B or C infection
- Active Tuberculosis
- Conditions or therapies that interfere with study participation or safety
- Psychiatric or substance abuse disorders interfering with cooperation
- Prior allogeneic tissue or organ transplant
- Significant cardiovascular disease within 12 months including severe heart failure or unstable angina
- Prolonged QTcF interval above 480 ms
- Bleeding or clotting disorders with risk of severe hemorrhage
- Active peritonitis or diverticulitis
- Medical or surgical history contraindicating intraperitoneal therapy such as extensive adhesions or prior HIPEC
- History of severe hypersensitivity to biologic therapies such as monoclonal antibodies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
P
Paula M Smith, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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