HPV-16/18 E6/E7-Specific T Lymphocytes, Relapsed HPV-Associated Cancers, HESTIA
Status:
Recruiting
Trial end date:
2033-10-01
Target enrollment:
Participant gender:
Summary
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, to learn what the side effects are and to see if the HPVSTs will help
people with HPV associated cancers.
If the treatment with HPVST cells alone proves safe (Group A), additional group of patients
(Group B) will receive Nivolumab in addition to HPVST cells in a lymphodepleted environment.
Nivolumab is an antibody therapy that helps T cells control the tumor and it is FDA approved
for the treatment of certain types of cancers, including Hodgkin's lymphoma. Lymphodepletion
will decrease the level of circulating T cells prior to infusion of HPVST cells, thereby
giving them room to expand. The purpose of this part of the study is to find out if TGF-beta
resistant HPVST cells in combination with Nivolumab are safe, how long they last in the body
and if they are more effective than HPVST cells alone in controlling the tumor.
Phase:
Phase 1
Details
Lead Sponsor:
Baylor College of Medicine
Collaborators:
Center for Cell and Gene Therapy, Baylor College of Medicine The Methodist Hospital Research Institute