Back to search results

TROP2 CAR-NK Cells with Cetuximab for Colorectal Cancer with Minimal Residual Disease

This study is testing a new combination treatment for colorectal cancer (CRC) in people who have minimal residual disease (MRD), meaning a small amount of cancer cells remain after initial treatment. The treatment involves TROP2-CAR-NK cells (a type of immune cell engineered to fight cancer) given with cetuximab (a targeted therapy). Researchers want to find the safest and most effective dose of TROP2-CAR-NK cells when combined with cetuximab. You might also receive fludarabine phosphate, cyclophosphamide, and rimiducid. The study will look at how safe the treatment is and any side effects you might experience. To join, you must be at least 18 years old and willing to follow study instructions. The study aims to enroll 42 participants.

Study design
This is an interventional study that plans to enroll 42 participants. It is designed to find the best dose of the new treatment combination.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety and any side effects will be measured throughout the study, which is expected to last an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06358430

Dose Escalation and Expansion Study of TROP2 CAR Engineered IL-15- Transduced Cord Blood-derived NK Cells in Combination With Cetuximab in Patient With Colorectal Cancer (CRC) With Minimal Residual Disease (MRD)

Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~10 participants
Updated 2026-08-04 on ClinicalTrials.gov
What's tested:Fludarabine PhosphateCyclophosphamideCetuximabTROP2-CAR-NK CellsRimiducid (AP1903)Lymphodepleting Chemotherapy

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and adverse events (AEs)
Measured over Through study completion; an average of 1 year.

Conditions

Colorectal Cancer
Minimal Residual Disease

Explore related trials

Colorectal CarcinomaCirculating Tumor-Derived DNA Negative

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Maria Pia Morelli, MD, PhD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Not a woman of childbearing potential (WOCBP) as defined in Appendix 4 OR
A WOCBP who agrees to follow the contraceptive guidelines in Appendix 4 during the study treatment period and for 6 months post TROP2-CAR-NK cell infusion. 8. Female participants who become pregnant or suspect pregnancy must immediately notify their doctor. Females' participants who become pregnant will be taken off study. 9. Male participants must agree to follow the contraceptive guidelines in Appendix 4 during the study treatment period and for 6 months post TROP2-CAR-NK cell infusion. Male participants who father a child or suspect that they have fathered a child must immediately notify their doctor. 10. WOCBP must have a negative urine pregnancy test within 72 hours prior to the start of lymphodepleting chemotherapy. If a WOCBP has a urine pregnancy test that cannot be confirmed as negative, a serum (beta-human chorionic gonadotropin \[â-hCG\]) pregnancy test will be required. 11. Participants must have adequate organ function as defined below (Table 1) within 10 days prior to the start of lymphodepleting chemotherapy:

What this trial measures

  • Safety and adverse events (AEs)Through study completion; an average of 1 year.

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0