OncoMatch/Clinical Trials/NCT05639972
E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers
Is NCT05639972 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1/2 trial studies multiple treatments including E7 TCR-T cells and Aldesleukin for hpv-associated cervical carcinoma.
Treatment: E7 TCR-T cells · Aldesleukin — The goal of this study is to determine the feasibility of administration of a single dose of E7 TCR-T cells as induction therapy prior to definitive treatment (chemoradiation or surgery) of locoregionally advanced HPV-associated cancers. The intent of E7 TCR-T cell treatment is to shrink or eliminate tumors and thereby facilitate definitive therapy and increase overall survival. This study seeks to determine 1) if E7 TCR-T cells can be administered without undue delay in definitive treatment, 2) the tumor response rate to E7 TCR-T cell treatment, and 3) the disease-free survival rate at 2 and 5 years. Participants will undergo an apheresis procedure to obtain T cells that will be genetically engineered to generate E7 TCR-T cells. They will receive a conditioning regimen, a single infusion of their own E7 TCR-T cells, and adjuvant aldesleukin. Participants will follow up to assess safety and determine tumor response and will return to their primary oncology team for definitive therapy.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Cervical Cancer
Head and Neck Squamous Cell Carcinoma
Penile Carcinoma
Biomarker criteria
Required: HPV16 genotype
Tumor with HPV16 genotype as determined by testing performed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory.
Required: HLA-A a*02:01 allele
HLA-A*02:01 allele determined by testing performed in a 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 research or clinical sequencing will not be eligible.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic therapy or definitive chemoradiation for the cancer that is being treated on this protocol
Exception: Palliative radiation therapy for symptom management, such as to control tumor-induced bleeding, is permitted.
Have received prior systemic therapy or definitive chemoradiation for the cancer that is being treated on this protocol. Palliative radiation therapy for symptom management, such as to control tumor-induced bleeding, is permitted.
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 aminotransferase (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 aminotransferase (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
- 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 NCT05639972 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require HPV16?
Yes, HPV16 genotype 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