RecruitingPhase 1NCT07101432

Phase I Study of Preconditioning Radiation Therapy With IL-15 Transduced TGFBR2 KO CAR.TROP2-engineered Cord Blood-derived NK Cells in Patients With Advanced Head and Neck Cancer (RADIANCE-NK)


Sponsor

M.D. Anderson Cancer Center

Enrollment

33 participants

Start Date

Nov 4, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

To find the recommended dose of an investigational therapy called chimeric antigen receptor (CAR).TROP2/interleukin (IL)15-transduced TGFBR2 KO cord blood (CB)-derived natural killer (NK) cells (TROP2 CAR/IL-15 TGFBR2 KO NK cells) that can be given with and without preconditioning radiation therapy in patients with advanced head and neck squamous cell carcinoma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study is testing a new type of immune cell therapy — specially engineered natural killer (NK) cells — combined with radiation, in people with advanced head and neck cancer that has not responded to standard treatments. **You may be eligible if...** - You have been diagnosed with head and neck cancer that has spread or cannot be removed by surgery - Your cancer has come back or stopped responding to standard treatments - Your tumor tests positive for a protein called TROP2 - You are well enough to participate (good performance status) **You may NOT be eligible if...** - You received chemotherapy less than 2 weeks ago, or targeted therapy less than 3 days ago - You received a cell-based therapy (such as CAR-T) within the last 3 months - You have certain heart, liver, kidney, or lung problems that make treatment unsafe 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

Given by infusion

DRUGCyclophosphamide

Given by infusion


Locations(1)

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT07101432


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