E7 TCR-T Cell Immunotherapy for Human Papillomavirus (HPV) Associated Cancers

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
Christian Hinrichs
Study ID
NCT05686226
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Anal Cancer
  • Cervical Cancer
  • HPV Positive Oropharyngeal Squamous Cell Carcinoma
  • HPV Positive Rectal Squamous Cell Carcinoma
  • HPV-Associated Vaginal Adenocarcinoma
  • HPV-Related Adenocarcinoma
  • HPV-Related Adenosquamous Carcinoma
  • HPV-Related Anal Squamous Cell Carcinoma
  • HPV-Related Carcinoma
  • HPV-Related Cervical 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
  • Metastatic Cancer
  • Oropharynx Cancer
  • Penile Cancer
  • Throat Cancer
  • Vaginal Cancer
  • Vulva 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 every eight hours will be administered for up to six 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

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.

Key Dates

Start date
Mar 7, 2023
Status verified
Feb 2026
Primary completion
Jan 1, 2027
Completion
Jan 1, 2027

Study Design

Enrollment
20 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

Tumor response [ Time Frame: 5 years ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
Laura A Parsons-Wandell, RN
[email protected]
240-858-7480
Scott M Norberg, DO
[email protected]
301-275-9668
Scott M Norberg, DO (PRINCIPAL_INVESTIGATOR)
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 Bethesda, MD

By condition
Cervical cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
National Institutes of Health Clinical Center· Bethesda, MDRutgers Cancer Institute· New Brunswick, NJRWJBarnabas Health - Robert Wood Johnson University Hospital· New Brunswick, NJ

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