OncoMatch/Clinical Trials/NCT04713046
Safety and Efficacy of Allogeneic HPV-specific T Cells in Adults With Recurrent or Metastatic HPV16+ Cancers
Is NCT04713046 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including CD8 reduced peripheral blood cells taken from related donors vaccinated against HPV16 and Non-myeloablative allogeneic bone marrow transplant from related donors vaccinated against HPV16 for hpv 16+ recurrent or metastatic cancer.
Treatment: CD8 reduced peripheral blood cells taken from related donors vaccinated against HPV16 · Non-myeloablative allogeneic bone marrow transplant from related donors vaccinated against HPV16 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Biomarker criteria
Required: HPV16 positive
HPV16+ HNSCC
Disease stage
Metastatic disease required
pathologically confirmed incurable, locally recurrent or metastatic HPV16+ HNSCC
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy
Prior treatment with a platinum-containing regimen
Must have received: anti-PD-1 therapy
Patients with an FDA-approved indication to receive an anti-programmed cell death protein-1 (PD-1) or anti-programmed death-ligand1 (PD-L1) monoclonal antibody must have received at least one cycle of this therapy prior to receiving treatment on this trial
Cannot have received: HPV T cells
Prior treatment with HPV T cells
Lab requirements
Kidney function
Serum creatinine < 3.0 mg/dl
Liver function
Total bilirubin < 3.0 mg/dl unless from Gilbert disease; AST and ALT < 4 x institutional upper limit of normal
Cardiac function
Left ventricular ejection fraction > 35% (within 30 days of eligibility screening)
Left ventricular ejection fraction > 35% (within 30 days of eligibility screening); Total bilirubin < 3.0 mg/dl unless from Gilbert disease; AST and ALT < 4 x institutional upper limit of normal; Serum creatinine < 3.0 mg/dl
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Baltimore, Maryland
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