Finding studies
Finding studies
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Lead
National Cancer Institute (NCI)
Background: * Metastatic or refractory/recurrent human papillomavirus (HPV)-16+ cancers (cervical, vulvar, vaginal, penile, anal, and oropharyngeal cancers) are incurable and poorly palliated by standard therapies. * HPV-16+ cancers constitutively express the HPV-16 E7 oncoprotein, which is absent from healthy human tissues. * Administration of T cell receptor (TCR) gene engineered T cells can induce objective tumor responses in certain malignancies including HPV-16+ cancers. * T cells genetically engineered with a TCR targeting HPV-16 E7 (E7 TCR) display specific reactivity against human leukocyte antigen (HLA)-A2+, HPV-16+ target cells. Objectives: Phase I Primary Objective \- To determine a safe dose for E7 TCR cells plus aldesleukin for the treatment of metastatic HPV-16+ cancers. Phase II Primary Objective -To determine safety and efficacy of E7 TCR cells plus aldesleukin for the treatment of metastatic HPV-16+ cancers. Eligibility: * Patients greater than or equal to 18 years old with metastatic or refractory/recurrent HPV-16+ cancer. * Prior first line systemic therapy is required unless the patient declines standard treatment. * Patients must be HLA-A\*02:01-positive. Design: * This is a phase I/II clinical trial that will test the safety and efficacy of E7 TCR cells. * All patients will receive a non-myeloablative lymphocyte-depleting preparative regimen of cyclophosphamide and fludarabine followed by a single infusion of E7 TCR cells. Cell infusion will be followed by high dose aldesleukin. * Re-enrollment will be allowed for a small number of subjects.
Age
18–120
Sex
ALL
Healthy volunteers
Not accepted
