E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers

Part of paid clinical trials in New Brunswick, New Jersey.

Sponsor
Christian Hinrichs
Study ID
NCT05639972
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Anal Cancer
  • Cervical Cancer
  • HPV Positive Oropharyngeal Squamous Cell Carcinoma
  • HPV-Associated Cervical Carcinoma
  • HPV-Related Adenocarcinoma
  • HPV-Related Adenosquamous Carcinoma
  • HPV-Related Anal Squamous Cell Carcinoma
  • HPV-Related Carcinoma
  • HPV-Related Endocervical Adenocarcinoma
  • HPV-Related Malignancy
  • HPV-Related Penile Squamous Cell Carcinoma
  • HPV-Related Squamous Cell Carcinoma
  • HPV-Related Vulvar Squamous Cell Carcinoma
  • Oropharynx Cancer
  • Penile Cancer
  • Vaginal Cancer
  • Vulvar Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • E7 TCR-T cells — BIOLOGICAL
    Participants will receive a conditioning regimen consisting of cyclophosphamide and fludarabine. E7 TCR-T cells will be administered as a single intravenous infusion.
  • Aldesleukin — DRUG
    Within 24 hours after E7 TCR-T cell infusion, aldesleukin 720,000 IU/kg IV will be administered every 8 hours as an inpatient for up to 3 doses. Aldesleukin dosing will be stopped for aldesleukin-related grade 3 or greater toxicity other than flushing, fever, chills, or hemodynamic changes (tachycardia or hypotension) that respond to crystalloid infusion. Aldesleukin may also be stopped at any time at investigator discretion.

Study Details

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.

Key Dates

Start date
Aug 11, 2025
Status verified
Feb 2026
Primary completion
Oct 1, 2026
Completion
Oct 1, 2026

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: E7 TCR-T cells
    Subjects will receive a conditioning regimen, E7 TCR-T cells, and aldesleukin.

Primary Outcome Measure

Feasibility of administering E7 TCR-T cell therapy as induction treatment for LAHPVC [ Time Frame: 6 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Rutgers Cancer InstituteNew BrunswickNew Jersey08901
Tobi Adewale
[email protected]
732-710-2406
RWJBarnabas Health - Robert Wood Johnson University HospitalNew BrunswickNew Jersey08901
Tobi Adewale
[email protected]
732-710-2406

Find similar trials in New Brunswick, NJ

By condition
Cervical cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Rutgers Cancer Institute· New Brunswick, NJRWJBarnabas Health - Robert Wood Johnson University Hospital· New Brunswick, NJ

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