Pilot study to evaluate the potential of growing out tumor infiltrating lymphocytes from cervical carcinoma

The presence of intratumoral immune cells and in particular CD8 (cytotoxic) T
cells has been associated with favorable prognosis in several malignancies
including melanoma, ovarian cancer and colorectal cancer. These observations
have in large part inspired the development of adoptive T cell therapy with
tumor infiltrating lymphocytes (TIL) as the treatment modality for metastasized
disease, often using melanoma as a platform. Previous clinical trials in
melanoma patients have achieved clinical responses in approximately 50% of
stage IV melanoma patients.
Importantly, thus far, melanoma remains the only disease for which TIL therapy
has reproducibly shown these results. The goal to expand TIL treatment to other
entities besides melanoma is one of the pillars of the business case for cell
therapy. Cervical carcinoma is an attractive candidate as almost all (estimated
around 95%) of the tumors are Human Papilloma Virus (HPV) related tumors.
Previous clinical trials in cervical cancer patients have showed objective
response rates (ORR) ranging from 25%-44% with TIL therapy. Therefore, we want
to expand the TIL therapy program to this entity as well.

This study aims to evaluate the potential of growing out TIL from several
patients with cervical carcinoma.

This is a pilot study where patient material will be collected and utilized for
translational research purposes.

not applicable

The expected risks or side*effects of taking additional biopsies are low.
Nevertheless, there is a small chance for complications in the form of
infection or bleeding. Standard procedures will be followed in case any of
these complications occur, to ensure the safety of the patient.