OncoMatch/Clinical Trials/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)
Is NCT07101432 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Fludarabine and Cyclophosphamide for head and neck cancer.
Treatment: Fludarabine · Cyclophosphamide — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: TACSTD2 overexpression (2+ or 3+ by IHC) (2+ or 3+ by IHC)
Patient tumors must demonstrate TROP2 expression of 2+ or 3+ as determined by IHC at the MDACC CAP and CLIA accredited Clinical Laboratories.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: local standard treatments that are known to prolong survival
relapsed or progressed following local standard treatments that are known to prolong survival, or for which no standard treatment is available or are no longer effective, or refused such therapy
Cannot have received: CAR T or NK cell or other genetically modified T or NK cell therapy
Prior CAR T or NK cell or other genetically modified T or NK cell therapy
Lab requirements
Blood counts
ANC ≥ 1500/µL; Platelets ≥ 100,000/µL; Hemoglobin ≥9.0 g/dL (criteria must be met without erythropoietin dependency and without packed red blood cell transfusion within last 2 weeks of the screening test)
Kidney function
Creatinine ≤ 1.5 x ULN OR CrCl by Cockcroft-Gault ≥30 mL/min for patients with creatinine > 1.5 x ULN
Liver function
Total bilirubin ≤1.5 x ULN OR direct bilirubin ≤ ULN for patients with total bilirubin levels >1.5 x ULN; AST and ALT ≤2.5 x ULN (≤5 x ULN for patients with liver metastases)
Cardiac function
Left ventricular ejection fraction >50%; New York Heart Association Functional Classification class 2B or better
Adequate organ function as defined below within 10 days prior to the start of lymphodepleting chemotherapy: ... See Table 1. ... Left ventricular ejection fraction >50%. ... New York Heart Association Functional Classification class 2B or better.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- The University of Texas M. D. Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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