E7 TCR-T Cell Immunotherapy for Human Papillomavirus (HPV) Associated Cancers (NCT05686226) | Clinical Trial Compass
RecruitingPhase 2
E7 TCR-T Cell Immunotherapy for Human Papillomavirus (HPV) Associated Cancers
United States20 participantsStarted 2023-03-07
Plain-language summary
This is a phase II clinical trial to assess the clinical activity of immunotherapy with E7 TCR-T cells for metastatic HPV-associated cancers. HPV-associated cancers in include cervical, throat, penile, vulvar, vaginal, anal, and other cancers. Participants will receive a conditioning regimen, E7 TCR-T cells, and aldesleukin. Clinical response to treatment will be determined.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Histologically or cytologically confirmed metastatic or refractory/recurrent HPV-16+ cancer.
✓. Tumor with HPV16 genotype as determined by testing performed in a CLIA certified laboratory.
✓. HLA-A\*02:01 allele as determined by testing performed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory. Participants may be enrolled based on low resolution typing (i.e., HLA-A\*02) but the HLA-A\*02:01 allele type must be confirmed prior to apheresis.
✓. Measurable disease as assessed by RECIST Criteria Version 1.1.
✓. Age ≥ 18 years.
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at screening.
✓. Must have received prior first line standard therapy or have declined standard therapy.
✓. Standard treatment options for first and second-line therapy must be presented and formally declined (Appendix VII).
Exclusion criteria
✕. Uncontrolled intercurrent illness such as 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.
✕. History of severe allergic reactions to compounds of similar chemical or biological composition to agents used in this study.
. History of coronary revascularization or ischemic symptoms unless patient has a normal cardiac stress test.
✕. Documented LVEF of less than or equal to 45% tested. The following participants will undergo cardiac evaluations:
✕. Clinically significant atrial and/or ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block or
✕. Age \> 50 years old
✕. Participants with baseline screening pulse oxygen level of \< 92% on room air will not be eligible. If the underlying cause of hypoxia improves, then they may be reevaluated.
✕. Subjects with HLA-A\*02:01 damaging mutation or allele loss detected by clinical or research genomic profiling will not be eligible.