OncoMatch/Clinical Trials/NCT05686226
E7 TCR-T Cell Immunotherapy for Human Papillomavirus (HPV) Associated Cancers
Is NCT05686226 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including E7 TCR-T cells and Aldesleukin for cervical cancer.
Treatment: E7 TCR-T cells · Aldesleukin — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Cervical Cancer
Head and Neck Squamous Cell Carcinoma
Penile Carcinoma
Tumor Agnostic
Biomarker criteria
Required: HPV16 genotype positive
Tumor with HPV16 genotype as determined by testing performed in a CLIA certified laboratory
Required: HLA-A A*02:01 allele
HLA-A*02:01 allele as determined by testing performed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory
Excluded: HLA-A A*02:01 damaging mutation or allele loss
Subjects with HLA-A*02:01 damaging mutation or allele loss detected by clinical or research genomic profiling will not be eligible
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard therapy — first line
Must have received prior first line standard therapy or have declined standard therapy
Lab requirements
Blood counts
Leukocytes > 3,000/mcL; Absolute neutrophil count > 1,500/mcL; Platelets > 100,000/mcL; Hemoglobin > 9.0 g/dL
Kidney function
Calculated creatinine clearance (CrCl) >50 mL/min/1.73 m2 for participants with creatinine levels above institutional normal (by the CKD-EPI equation)
Liver function
Total bilirubin within normal institutional limits except in participants with Gilbert's Syndrome who must have a total bilirubin < 3.0 mg/dL. Serum aspartate transferase (AST) (SGOT)/alanine transaminase (ALT) (SGPT) < 2.5 x upper limit of normal (ULN)
Cardiac function
Documented LVEF of less than or equal to 45% tested [excluded]. Cardiac evaluation for clinically significant arrhythmias or age > 50 years.
Participants must have organ and marrow function as defined below: Leukocytes > 3,000/mcL; Absolute neutrophil count > 1,500/mcL; Platelets > 100,000/mcL; Hemoglobin > 9.0 g/dL; Total bilirubin within normal institutional limits except in participants with Gilbert's Syndrome who must have a total bilirubin < 3.0 mg/dL. Serum aspartate transferase (AST) (SGOT)/alanine transaminase (ALT) (SGPT) < 2.5 x upper limit of normal (ULN); Calculated creatinine clearance (CrCl) >50 mL/min/1.73 m2 for participants with creatinine levels above institutional normal (by the CKD-EPI equation).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
- Rutgers Cancer Institute · New Brunswick, New Jersey
- RWJBarnabas Health - Robert Wood Johnson University Hospital · New Brunswick, New Jersey
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05686226 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received standard therapy.
Does this trial require HPV16?
Yes, HPV16 genotype positive is a required biomarker for enrollment.
Does this trial require HLA-A?
Yes, HLA-A A*02:01 allele is a required biomarker for enrollment.
Are patients with HLA-A alterations eligible?
No. HLA-A A*02:01 damaging mutation or allele loss is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify