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 (May 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
Cancer type
Head and Neck Squamous Cell Carcinoma
Penile Carcinoma
Cervical Cancer
Biomarker criteria
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
Prior systemic therapy or definitive chemoradiation for the cancer that is being treated on this protocol.
Cannot have received: definitive chemoradiation
Prior systemic therapy or definitive chemoradiation for the cancer that is being treated on this protocol.
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
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