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:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT04411134
Eligibility Criteria:
* INCLUSION CRITERIA:
* Patients must have histologically confirmed high-grade cervical intraepithelial neoplasia (CIN 2,3). Confirmation of high-grade cervical intraepithelial neoplasia (pathology report from outside institution is sufficient). Pathology confirming high-grade CIN must be within 3 months prior to initiation of study therapy. If needed, confirmatory biopsy of lesion(s) may be performed.
* HPV16+ CIN 2,3 and HLA-A\*02:01 HLA type
* Patients may be treatment-naive or have received previous treatment for high-grade CIN. Patients who have received previous treatment are eligible if prior treatment was greater than or equal to 3 months before first dose of E7 TCR T cells and there is pathological confirmation of recurrent or persistent disease. If needed, confirmatory biopsy of lesion(s) may be performed.
* Patients can have either one lesion or multiple lesions with at least one lesion being visible on colposcopy to help facilitate intralesional administration of E7 TCR T cells.
* Age greater than or equal to 21 years. Because treatment for this disease is not recommended in patients \<21 years of age, children and adolescents \<21 years old are excluded from this study.
* ECOG performance status greater than or equal to 2.
* Patients must have adequate 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 1.5X 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
* creatinine clearance Calculated creatinine clearance (CrCl) \>50mL/min/1.73m\^2 for patient with creatinine levels above institutional normal (by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation)
* Women of child-bearing potential must have a negative pregnancy test because E7 TCR T cells have unknown potential for teratogenic or abortifacient effects. Women of childbearing 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 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 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, 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, active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations 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. These potential risks may also apply to other agents used in this study.
* 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 including systemic corticosteroids (inhaled or intranasal corticosteroids are allowed).
* Patients with a second active invasive cancer are not eligible.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
21 Years
Study:
NCT04411134
Study Brief:
Protocol Section:
NCT04411134