Background:
More than 12,000 cases of cervical cancer are diagnosed in the United States each year. A new
therapy has been developed that involves taking white blood cells from a person, genetically
modifying the cells in a lab so they recognize cancer, and then giving the cells back to the
person. Researchers want to see if this therapy can help people with cervical cancer.
Objective:
To find out if people with Stage IIB-IVA cervical cancer can safely be given E7 T-cell
receptor (TCR) T cells before they get standard treatment.
Eligibility:
People age 18 and older who have Stage IIB-IVA cervical cancer
Design:
Participants will be screened under a separate protocol. Tests will include:
- Physical exam
- Medicine review
- Blood tests
- Pregnancy test (if needed)
- Vein assessment
- Tumor sample or biopsy
- Electrocardiogram (to record the hearts electrical activity)
- Imaging scans, x-rays, and/or endoscopy
- Heart and/or lung tests.
Some screening tests will be repeated during the study.
Participants will undergo leukapheresis. For this, blood is removed through a needle in the
arm. A machine removes the white blood cells. The rest of the blood is returned through a
needle in the other arm. Participants may need to have a large catheter inserted into a vein.
Participants will stay at the hospital for 2-3 weeks. They will get chemotherapy drugs. They
will get the E7 TCR T cells as an intravenous infusion. They will get the drug aldesleukin.
Participants will visit the National Institutes of Health (NIH) 3 and 6 weeks after
treatment. They will be contacted yearly for 5 years. They will be asked to participate in
long-term follow-up for 15 years....
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04476251.
Background:
- Cervical cancer is the third most common cause of death among women with gynecologic
cancers in the United States. Worldwide, cervical cancer accounts for nearly 300,000
deaths annually.
- Virtually all cases of cervical cancer result from chronic infection with high-risk
human papillomavirus (HPV), the most common type being HPV16.
- The treatment of locally advanced cervical cancer consists of chemoradiation +/-
extended field radiation therapy. Participants with International Federation of
Gynecology and Obstetrics (FIGO) (revised 2018) stage III-IVA have the worse prognosis
with approximately 50% of the participants dying from their disease within 5 years.
- Induction chemotherapy is an active area of study in this type of cancer. The aim of
induction therapy is to reduce the risk of disease recurrence and improve overall
survival.
- E7 T-cell receptor (TCR) T cells, administered as a single infusion, have demonstrated
safety and clinical activity in advanced, treatment-refractory metastatic HPV+ cancers.
Objectives:
-To determine the feasibility of induction E7 TCR T cell therapy for FIGO (2018) stage
IIB-IVA, HPV16+ cervical cancer
Eligibility:
- Participants greater than or equal to 18 years old with FIGO (2018) stage IIB-IVA
cervical cancer.
- The cancer must be human papillomavirus 16 (HPV16+) and participant must be
HLA-A*02:01+.
- Participants must be treatment-naive (i.e., no prior local or systemic treatment,
including radiation; prior loop electrosurgical excision procedure (LEEP) procedure or
cone biopsy is allowed).
Design:
- This is a single arm, pilot study, testing the feasibility of induction E7 TCR T cell
therapy.
- Participants will receive a conditioning regimen of cyclophosphamide and fludarabine, a
single infusion of E7 TCR T cells, and systemic aldesleukin.
- Participants will be referred for standard of care definitive therapy (i.e.,
chemoradiation +/- extended field radiation therapy) within 6 weeks after infusion of E7
TCR T cells.
Lead OrganizationNational Cancer Institute
Principal InvestigatorChristian Sutter Hinrichs
