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Human Papillomavirus-Associated Cancers - Healing Genes
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Human Papillomavirus-Associated Cancers

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E7 TCR T Cells for Human Papillomavirus-Associated Cancers

A Phase I/II Trial of T Cell Receptor Gene Therapy Targeting HPV-16 E7 With or Without PD-1 Blockade for HPV-Associated Cancers


Phase 1 / 2

DESCRIPTION:

The National Institutes of Health Clinical Center seeks several patients with human papillomavirus-associated cancers that are metastatic, recurrent, or refractory. This includes (HPV)-16+ cancers (cervical, vulvar, vaginal, penile, anal, and oropharyngeal cancers). These patients may be eligible to trial an investigatory gene therapy that removes certain immune blood cells, gene-modifies them in the lab to target their cancer cells, then restores them to the patient.

The treatment would require screening and leukapheresis to remove the targeted immune cells, then later admitted to the hospital to receive a round of chemotherapy, the gene-modified cells and a drug to promote their growth. Follow up will continue for 15 years.


PATIENT MUST:

  • Be 18 to 70 years of age
  • Have a diagnosis (HPV)-16+ associated cancers
  • Must have received prior first line standard therapy or declined standard therapy.
  • Be willing to use birth control, if sexually active, and not be pregnant

THE STUDY INVOLVES:

  1. Screening to confirm eligibility, including imaging procedures, heart and lung tests, and lab tests.
  2. Participant will have leukapheresis: blood will be removed through a needle in the arm while a machine separates the white blood cells. The rest of the blood is returned through a needle in the other arm.
  3. No treatment while the cells are gene-modified in the lab.
  4. Admission to hospital and over several days, chemotherapy drugs and then the gene-modified immune cells are injected. Injections to stimulate the cells will be given.
  5. Participants will be monitored in the hospital up to 12 days with support medicine, blood and lab tests.
  6. Clinic visit about 40 days after cell infusion including physical exam, blood work, scans, and possibly x-rays.
  7. Similar follow up visits for several months, with long term follow up for 15 years.

LOCATIONS AND CONTACTS:

The study site is at the National Institutes of Health Clinical Center in Bethesda, MD. Map.
 
Contacts:
Erin W Ferraro, R.N.  |  (833) 815-0387  |  [email protected]
 
SPONSOR INFORMATION:
National Cancer Institute (NCI)
 
Or go online:
https://clinicaltrials.gov/ct2/show/NCT02858310

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