Actively Recruiting
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)
Led by M.D. Anderson Cancer Center · Updated on 2026-05-06
33
Participants Needed
1
Research Sites
216 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with histologically confirmed head and neck cancer, HPV positive or negative, that is locally advanced and unresectable or metastatic with 5 or fewer disease sites
- Cancer that has relapsed or progressed after standard treatments or for which no standard treatment is available or effective
- Tumors must show TROP2 expression level 2+ or 3+ by immunohistochemistry
- At least 2 weeks since last cytotoxic chemotherapy and 3 days since last targeted therapy before lymphodepleting chemotherapy
- Radiation therapy allowed to one or more disease sites before lymphodepleting chemotherapy
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 3 months
- Female patients not of childbearing potential or females of childbearing potential who agree to use contraception during treatment and 6 months after infusion
- Negative pregnancy test for women of childbearing potential before chemotherapy
- Agreement to use effective contraception for both female and male patients during study and 6 months after treatment
- Measurable disease according to RECIST v1.1
- Adequate organ function as defined by laboratory values within 10 days before lymphodepleting chemotherapy
- Left ventricular ejection fraction greater than 50%
- Adequate respiratory reserve with mild or no shortness of breath
- Prior treatment with TROP2-targeted therapy allowed
- Willingness to undergo mandatory blood collections and biopsies
- Willingness to sign consent for long-term follow-up
- Willingness to stay within a 2-hour drive of study site during first 4 weeks after infusion
- Patients with prior or concurrent malignancy that does not interfere with study participation
- Patients with known or treated cardiac disease with New York Heart Association Functional Classification Class 2B or better
- Ability to understand and sign informed consent
You will not qualify if you...
- Pregnant, breastfeeding, or planning pregnancy during the study and 6 months after infusion
- Received systemic anticancer therapy within 2 weeks or 5 half-lives (whichever is shorter) before lymphodepleting chemotherapy
- Patients not recovered from adverse events of prior therapies to grade 1 or baseline, except some mild neuropathy or alopecia
- Radiation therapy within 2 weeks before lymphodepleting chemotherapy if requiring corticosteroids or history of radiation pneumonitis
- Received live vaccine within 6 weeks before infusion and for 24 months after
- Prior CAR T or NK cell or other genetically modified T or NK cell therapy
- Diagnosis of immunodeficiency or on chronic systemic steroids over 10 mg prednisone equivalent daily
- History of second malignancy unless treated and disease-free for 2 years, except certain skin or in situ cancers
- Active central nervous system metastases or carcinomatous meningitis
- Active autoimmune disease requiring systemic treatment in past 2 years
- History of interstitial lung disease requiring steroids or current pneumonitis/ILD
- Active infection requiring systemic therapy
- Known HIV infection
- Known active or chronic hepatitis B or C infection
- History of active tuberculosis
- Any condition or therapy interfering with study participation or safety
- Psychiatric or social issues limiting compliance
- History of allogenic tissue or solid organ transplant
- Significant cardiovascular disease within 12 months before chemotherapy, except controlled arrhythmia
- Prolonged QT interval over 480 milliseconds
- Bleeding or clotting disorders or risk of severe bleeding (patients on anticoagulation for DVT/PE allowed)
- History of severe stomatitis or mucositis with prior therapy
- Allergic reactions to cyclophosphamide, fludarabine, or similar agents used in the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
G
Gohar Manzar, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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