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HPV-Associated Cancers - Healing Genes
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HPV-Associated Cancers

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

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


Phase 1

DESCRIPTION:
Researchers with Houston Methodist Hospital seek patients with HPV-associated cancers that are recurrent or refractory, or cannot receive standard therapy, to trial an experimental treatment using special immune system cells called HPVST cells drawn from the patient. In the lab, researchers will 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.

If the treatment with HPVST cells alone proves safe, an additional group of patients will receive Nivolumab alongside HPVST cells. 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. Follow up will continue for 6 weeks.


PATIENT MUST:

  • Be 18 years of age or older
  • Have a diagnosis of a cancer for which the presence of a high risk HPV type has been documented in a biopsy sample, and which meets clinical criteria.
  • Life expectancy ≥ 6 weeks

THE STUDY INVOLVES:

  1. Screening before the treatment (including lab tests, MRIs, physical assessments, and nerve biopsies).
  2. HPVSTs will be drawn, modified in the lab over several weeks, and given by IV injection over 1-10 minutes through a peripheral or a central line.
  3. If patients have clinical benefit (as determined by symptoms, physical exam or radiological studies) & no significant toxicities, they may get up to 5 repeat infusions (for max total of 6 infusions) of HPVSTs at or below the same dose level.
  4. Patients assigned to the second treatment group will receive chemotherapy prior to the re-infusion of HPVSTs, with Nivolumab to follow.
  5. Follow up continues for 6 weeks.

LOCATIONS AND CONTACTS:
Trials will take place at the National Institutes of Health Clinical Center in Bethesda, MD. Map.

Contact:
Carsten G Bonnemann, M.D.  |  (301) 594-5496  |  [email protected]
 
SPONSOR INFORMATION:
National Institute of Neurological Disorders and Stroke (NINDS)
 
Or go online:
https://clinicaltrials.gov/ct2/show/NCT02362438

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