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Safety and Efficacy of Allogeneic HPV-specific T Cells in Adults With Recurrent or Metastatic HPV16+ Cancers

NCT04713046 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-04-02

No results posted yet for this study

Summary

In this study, haploidentical relatives of a patient with recurrent or metastatic HPV 16-associated malignancy will be vaccinated with a therapeutic human papillomavirus (HPV) vaccine series to generate HPV-specific leukocytes. The cancer patient with recurrent or metastatic HPV16+ cancer will then be randomized to one of two arms: 1) non-myeloablative allogeneic bone marrow transplant or 2) cluster of differentiation 8 (CD8)-depleted donor lymphocyte infusion.

Conditions

  • HPV 16+ Recurrent or Metastatic Cancer

Interventions

BIOLOGICAL

CD8 reduced peripheral blood cells taken from related donors vaccinated against HPV16

Patients will receive CD8+ T cell-depleted peripheral blood cells at one of three dose levels following cyclophosphamide: 1) 10\^6 CD4+ cells/kg; 2) 5 x 10\^6 CD4+ cells/kg; or 3) 10\^7 CD4+ cells/kg of recipient ideal body weight.

BIOLOGICAL

Non-myeloablative allogeneic bone marrow transplant from related donors vaccinated against HPV16

Standard dosing for bone marrow graft (target dose of 4 x 10\^8 nucleated cells/kg) and if progression at Day 90, will receive dose level 1 for the CD8-depleted DLI (106 CD4+ cell/kg).

Sponsors & Collaborators

  • PapiVax Biotech, Inc.

    collaborator OTHER

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Philip Imus, MD · Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-18
Primary Completion
2026-10-01
Completion
2026-10-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04713046 on ClinicalTrials.gov