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

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years later Oct 1, 2026 → Oct 1, 2028
See other at-risk trials from Christian Hinrichs

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Oct 1, 2026 to Oct 1, 2028
    • Eligibility criteria expanded, about 14 words
    • Study description revised
    • Publications: details revised at 1 of 1 entry
  2. Eligibility criteria expanded, about 21 wordsv10
  3. Eligibility criteria shortened, about 4 wordsv9
  4. Start date changed from estimate of Mar 25, 2025 to Aug 11, 2025
    • Study sites revised (2)
    v8
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Oct 12, 2024 to Mar 25, 2025
    • Site details revised at 2 of 2 sites
    • Collaborators expanded, about 3 words
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. Start date: Jun 12, 2024 to Oct 12, 2024v6 Show 4 more changesShow less
    • Interventions: Conditioning, E7 TCR-T cells, and aldesleukin (Drug) to Aldesleukin (Drug), E7 TCR-T cells (Biological)
    • Eligibility criteria expanded, about 467 words
    • Site details revised at 2 of 2 sites
    • Collaborators shortened, about 4 words
  2. Trial status: Suspended to Not Yet Recruiting
    • Start date: Apr 2023 to Jun 12, 2024
    • Study sites: 1 to 2
    v5
  3. Trial status: Not Yet Recruiting to Suspended Sponsor's reason: Protocol Amendment
    • Start date: Jan 2023 to Apr 2023
    • Study description shortened, about 27 words
    • Site contact updated
    v4
  4. Lead sponsor: Rutgers, The State University of New Jersey to Christian Hinrichsv3
  5. Eligibility criteria expanded, about 33 words
    • Study description expanded, about 3 words
    • Study title expanded, about 3 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05639972
Lead Sponsor Christian Hinrichs
Collaborators: Iovance Biotherapeutics, Inc.
Conditions
(from sponsor)		 HPV-Associated Cervical Carcinoma, HPV-Related Carcinoma, HPV-Related Malignancy, HPV Positive Oropharyngeal Squamous Cell Carcinoma, HPV-Related Adenocarcinoma, HPV-Related Adenosquamous Carcinoma, HPV-Related Squamous Cell Carcinoma, HPV-Related Anal Squamous Cell Carcinoma +9 more
Related terms Anus Neoplasms, Oropharyngeal Neoplasms, Penile Neoplasms, Uterine Cervical Neoplasms, Vaginal Neoplasms, Vulvar Neoplasms
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov