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Phase I Study of CAR.TROP2-engineered NK Cells for Advanced Head and Neck Cancer

This Phase I study, called RADIANCE-NK, is testing a new investigational therapy for advanced head and neck cancer. The therapy uses special immune cells called Natural Killer (NK) cells that have been engineered to target cancer cells. These cells are called CAR.TROP2/IL-15 TGFBR2 KO NK cells. Researchers want to find the safest and most effective dose of these cells, given with or without radiation therapy, for patients whose cancer has returned or progressed after standard treatments, or for whom no standard treatment is available. The main goal is to check for safety and any side effects over about one year. This study is looking for 33 participants.

Study design
This is a Phase I interventional study with a planned enrollment of 33 participants. It is designed to determine the safety and recommended dose of the investigational therapy.
What's involved
Participants will receive infusions of Fludarabine and Cyclophosphamide, along with the investigational CAR.TROP2/IL-15 TGFBR2 KO NK cells. You will be carefully monitored for tumor response, symptom relief, safety, and tolerability.
Compensation
Not stated in the trial record.
Follow-up
Safety and adverse events will be measured through study completion, which is 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.

NCT07101432

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)

Recruiting
PHASE1Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~33 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:FludarabineCyclophosphamide

At a glance

Recruiting sites
1 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

Head and Neck Cancer

Explore related trials

Malignant Head and Neck NeoplasmTACSTD2 wt Allele

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Gohar Manzar, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Gohar Manzar, MD
[email protected]
713-792-4503
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

2 weeks from the last cytotoxic chemotherapy at the time of lymphodepleting chemotherapy; ≥3 days from last TKI or other targeted therapies at the time of lymphodepleting chemotherapy; ≥3 months from any cell therapy for any malignancy at the time of lymphodepleting chemotherapy; prior radiation therapy is allowed at the time of consent.
Postmenopausal (no menses in greater than or equal to 12 consecutive months).
History of hysterectomy or bilateral salpingo-oophorectomy.
Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
History of bilateral tubal ligation or another surgical sterilization procedure.

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