Phase 1Completed

HPV-16/18 E6/E7-Specific T Lymphocytes, Relapsed HPV-Associated Cancers, HESTIA

HPV-16/18 E6/E7-Specific T Lymphocytes in Patients With Relapsed HPV-Associated Cancers

Sponsor
Baylor College of Medicine (Academic or other)
Enrolment
35 enrolled
Conditions
Human Papillomavirus-Related Carcinoma; Human Papillomavirus Positive Oropharyngeal Carcinoma; Human Papillomavirus Positive Cervical Carcinoma; Human Papillomavirus Positive Anal Carcinoma; Human Papillomavirus Positive Vulvar Carcinoma; Human Papillomavirus Positive Penile Carcinoma
Interventions
HPV Specific T Cells; Cytoxan; Fludarabine; Nivolumab
Ages
adults, older adults
Registry
NCT02379520

Full record on ClinicalTrials.gov

From the registry

Subjects have a type of cancer that has been associated with an infection with a virus called human papilloma virus (HPV). The cancer has come back, has not gone away after standard treatment or the subject cannot receive standard treatment. This is a research study using special immune system cells called HPVST cells, a new experimental treatment. Investigators want to find out if they can use this type of treatment in patients with HPV-cancers. They have discovered a way to grow large number of HPV-specific T cells from the blood of patients with HPV-cancers. They want to see if these special white blood cells, called HPVST cells, that will have been trained to kill HPV infected cells can survive in the blood and affect the tumor. They will also see if they can make the T cells more active against the HPV-cancers by engineering them to be resistant to the TGF-beta chemical that these HPV-cancers produce. They will grow these HPVST cells from the patient's blood. The purpose of this study is to find the biggest dose of HPVSTs that is safe, to see how long they last in the body,…

Primary outcomes

  • Number of patients with dose limiting toxicity (DLT)

History

  1. Last registry update

  2. Primary completion

  3. Started

  4. Registered