Brief summary: A two part, single arm Phase II study is currently running at Herlev hospital, in Denmark. The study is designed to determine the safety and effectiveness of LTX-315 to induce T-cell infiltration prior to TIL expansion in patients with soft tissue sarcoma. Following intratumoural injection of LTX-315 to a selected lesion, the lesion will be extracted for T-cell culture, expansion and infusion.
More detailed description: Patients with advanced/metastatic tumours who have received at least one approved standard of care treatment will be recruited. All patients must have at least two lesions, one that can be injected with LTX-315 and another one that can used to assess response. In the first part of the study, 4 doses of LTX-315 will be administered intratumorally over a two week period to an index lesion which will be biopsied or removed after treatment for T-cell expansion. The second part will involve culturing and expanding T-cells for infusion of tumour infiltrating lymphocytes (TILs) following an induction regimen. The safety and efficacy of the LTX-315 and TIL treatment will be assessed. Patients will be followed up for 15 months.
For more information regarding the ongoing study, see clinicaltrails.gov or send an e-mail to ‘firstname.lastname@example.org’.