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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

October 18, 2023

Primary Completion Date

October 1, 2025

Study Completion Date

October 1, 2025

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).

Trial Locations (1)

21287

RECRUITING

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore

All Listed Sponsors
collaborator

PapiVax Biotech, Inc.

OTHER

lead

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER