Actively Recruiting
Dual Administration of Intraperitoneal and Intravenous TROP2-Directed CAR-NK with TGF-Beta Receptor 2 Knockout Therapy for Colorectal Cancer-Related Peritoneal Carcinomatosis: A Phase 1/2 Trial
Led by M.D. Anderson Cancer Center · Updated on 2026-04-23
28
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating a new treatment approach for patients with colorectal cancer that has spread to the peritoneum, a condition known as peritoneal carcinomatosis. This trial aims to find the highest safe dose of specially engineered immune cells called TROP2-directed CAR-NK cells with TGF-Beta Receptor 2 knockout, combined with the drug cetuximab, to evaluate safety and dosing schedules. The study is a Phase 1/2 trial sponsored by M.D. Anderson Cancer Center focusing on this advanced cancer that is not curable with standard treatments. Participants will receive the investigational treatment through two routes: intravenously (by vein) and intraperitoneally (directly into the abdominal cavity). The study includes a dose escalation phase to identify the maximum tolerated dose and a dose expansion phase to assess disease control at the recommended dose. Additional drugs such as cyclophosphamide and fludarabine are given intravenously as part of the treatment plan. Procedures include catheter placement for intraperitoneal delivery and scheduled fluid and blood sample collection. During the trial, participants will undergo regular monitoring for safety and adverse events over about one year. Assessments include diagnostic laparoscopy, organ function tests, biopsies, and blood tests to confirm eligibility and evaluate response. Researchers will closely follow symptoms, lab results, and tumor status to measure outcomes and manage any side effects. Participants are expected to complete all study visits and procedures as scheduled until study end or withdrawal.
CONDITIONS
Brief 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...
- Must be 18 years or older
- Histologically confirmed microsatellite stable colorectal cancer with peritoneal metastases not suitable for curative surgery
- Disease progressed after at least one line of standard systemic chemotherapy or intolerant to it
- No prior HIPEC operation; CRS without HIPEC allowed
- Adequate organ function as defined by study requirements
- Willing to undergo diagnostic laparoscopy and intraperitoneal catheter placement
- Limited extraperitoneal metastases (≤8 total) or at discretion of principal investigator
- Women of childbearing potential and men must agree to use effective contraception during and 4 months after treatment
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
- Recent systemic anti-cancer therapy within 4 weeks (6 weeks if including Bevacizumab)
- Recovery incomplete from previous therapy side effects above Grade 1 except select conditions
- Recent radiotherapy within 2 weeks before study start
- Live vaccine within 30 days before chemotherapy
- Current use of another investigational agent within 6 weeks prior to study
- Immunodeficiency or ongoing immunosuppressive therapy
- High volume extraperitoneal metastases beyond allowed limits
- Active autoimmune disease requiring recent systemic treatment
- History of interstitial lung disease requiring steroids or current pneumonitis
- Serious active infection requiring IV therapy
- Uncontrolled HIV, untreated Hepatitis B or C, active Tuberculosis
- Psychiatric or substance abuse disorders interfering with trial participation
- Prior allogeneic tissue or organ transplant
- Significant cardiovascular disease or prolonged QTc interval
- Bleeding or thrombotic disorders with risk of severe hemorrhage
- Extensive intraperitoneal adhesions, prior HIPEC, or large volume ascites
- Severe hypersensitivity to biologic therapies such as monoclonal antibodies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration depends on dosing schedule determined during the trial
Participants receive dual administration of NK cells by vein and directly into the abdominal cavity, combined with intravenous cetuximab and chemotherapy drugs cyclophosphamide and fludarabine to treat colorectal cancer-related peritoneal carcinomatosis.
Multiple visits for treatment administration and monitoring as scheduled
Duration - Up to 1 year after treatment
Participants are monitored for safety and adverse events after treatment completion.
Regular visits for safety assessments during follow-up
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
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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