drugset / Trial / NCT04713046
Safety and Efficacy of Allogeneic HPV-specific T Cells in Adults With Recurrent or Metastatic HPV16+ Cancers
Phase 1/2
Active not recruiting
24 enrolled
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
PapiVax Biotech, Inc. · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2023-10-18
- Primary completion
- 2026-10-01
- Completion
- 2026-10-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CD8 reduced peripheral blood cells | Unknown | 1e+06 cells/kg | — |
| Subject | CD8 reduced peripheral blood cells | Unknown | 5e+06 cells/kg | — |
| Subject | CD8 reduced peripheral blood cells | Unknown | 1e+07 cells/kg | — |