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")

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT07411599
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cyclophosphamide — DRUG
    Given by IV
  • Fludarabine — DRUG
    Given by IV
  • Cetuximab — DRUG
    Given by IV
  • NK Cells — DRUG
    Given by IV and IP

Study Details

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.

Key Dates

Start date
Apr 20, 2026
Status verified
Apr 2026
Primary completion
Nov 15, 2028
Completion
Nov 15, 2030

Study Design

Enrollment
28 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation
    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.
  • Experimental: Dose Expansion
    To learn if the recommended dose of NK cells found in Phase 1 given by vein and intraperitoneally in combination with cetuximab can help to control the disease.

Primary Outcome Measure

Safety and adverse events (AEs [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Paula M Smith, MD
[email protected]
713-792-3785
Paula M Smith, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Houston, TX

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
MD Anderson Cancer Center· Houston, TX

Related Studies