RecruitingPhase 1NCT06358430

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)

Phase 1 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)


Sponsor

M.D. Anderson Cancer Center

Enrollment

42 participants

Start Date

Dec 2, 2024

Study Type

INTERVENTIONAL

Summary

To find the highest and/or recommended dose of TROP2-CAR-NK cells combined with cetuximab in participants with MRD CRC.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new type of immune cell therapy — engineered NK (natural killer) cells that target a protein called TROP2 — combined with the drug cetuximab, in colorectal cancer patients who have had successful surgery and standard follow-up treatment but still have very small, undetectable traces of cancer (called minimal residual disease or MRD) detected through a blood test. **You may be eligible if...** - You are 18 or older - You have been diagnosed with colorectal cancer, had complete surgical removal of your tumor, and completed standard follow-up chemotherapy - Blood tests show signs of minimal residual disease (cancer DNA in the blood) even though imaging shows no visible cancer - You are in good overall health and able to follow study requirements **You may NOT be eligible if...** - You have visible cancer remaining or that has returned on scans - You have serious immune system problems or active autoimmune disease - You have significant heart, liver, or kidney dysfunction - You are pregnant or breastfeeding - You have had prior CAR-T or NK cell therapies Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFludarabine Phosphate

Given by IV

DRUGCyclophosphamide

Given by IV

DRUGCetuximab

Given by IV

DRUGTROP2-CAR-NK Cells

Given by IV

DRUGRimiducid (AP1903)

Given by IV

PROCEDURELymphodepleting Chemotherapy

Given by Chemotherapy


Locations(1)

MD Anderson Cancer Center

Houston, Texas, United States

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NCT06358430