NCT04713046

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

A Phase I Clinical Trial Assessing the Safety, Feasibility and Immunologic Correlates of Allogeneic HPV-specific Cluster of Differentiation 4 (CD4)+ T Cells in Advanced HPV16-associated Malignancies

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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).

Timeline

• Start date: 2023-10-18
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2021-01-19
• Last updated: 2026-04-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study