Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2025-12-24 @ 4:51 PM
NCT ID:
NCT04044950
Eligibility Criteria:
* INCLUSION CRITERIA:
* Histologically or cytologically confirmed stage I (AJCC 8th edition) oropharyngeal squamous cell carcinoma that has not been treated.
* HPV16+ tumor and HLA-A\*02:01+ HLA type (p16+ by THC and HLA-A\*02 is also acceptable for enrollment but not for treatment).
* Borderline/marginally resectable or unresectable oropharyngeal cancer. Resectability will be determined by the referring physician and confirmed by otolaryngologists at the NTH (confirmation is not needed for enrollment but is required prior to treatment.
* Measurable disease by RECTST v1.1 criteria.
* Patient age greater than 18 years. Because no dosing or adverse event data are currently available on the use of E7 TCR T cells in patients \<18 years of age, children are excluded from this study.
* ECOG performance status less than or equal to 2 (Karnofsky greater than or equal to 60%).
* Patients must have normal organ and marrow function as defined below:
* leukocytes greater than or equal to 3,000/mcL
* absolute neutrophil count greater than or equal to 1,500/mcL
* platelets greater than or equal to 100,000/mcL
* total bilirubin within normal institutional limits
* AST(SGOT)/ALT(SGPT) less than or equal to 2.5 X institutional upper limit of normal
* creatinine within normal institutional limits OR
* creatinine clearance greater than or equal to 60 mL/min/1.73 m(2) for patients with creatinine levels above institutional normal (calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation).
* Women of child-bearing potential must have a negative pregnancy test. Women of child-bearing potential are defined as all women who are not post-menopausal or who have not had a hysterectomy. Postmenopausal will be defined as women over the age of 55 who have not had a menstrual period in at least 1 year.
* The effects of E7 TCR T cells on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (intrauterine device, hormonal or barrier method of birth control; abstinence, tubal ligation or vasectomy) prior to study entry and for up to 4 months after treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
* Seronegative for HIV antibody. The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive can have decreased immune-competence and thus be less responsive to the experimental treatment.
* Seronegative for hepatitis B antigen and hepatitis C antibody. If hepatitis C antibody test is positive, then the patient must be tested for the presence of antigen by RT-PCR and be HCV RNA negative.
* Must be willing to participate in Gene Therapy Long Term Follow-up Protocol (20-C-0051), which will follow patients for up to 15 years per Food and Drug Administration (FDA) requirements.
* Ability of subject to understand and the willingness to sign a written informed consent document.
EXCLUSION CRITERIA:
* Patients who are receiving any other investigational agents.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations at the time of treatment that would limit compliance with study requirements.
* Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with E7 TCR T cells, breastfeeding should be discontinued if the mother is treated with E7 TCR T cells.
* Patients with any form of systemic immunodeficiency, including acquired deficiency such as HIV or primary immunodeficiency such as Severe Combined Immunodeficiency Disease, are ineligible. The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the treatment.
* Patients on immunosuppressive drugs.
* Concurrent systemic steroid therapy if greater than the equivalent of 5 mg prednisone PO daily. Patients previously on steroids must be off steroids for four weeks prior to treatment.
* Patients with active cardiac ischemia or severe chronic obstructive pulmonary disease are not eligible.
* Patients with a second active invasive cancer are not eligible if it may confound assessment of response to the current therapy.
* Patients who do not have a physician to provide standard therapy post cellular treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04044950
Study Brief:
Protocol Section:
NCT04044950