31TiP - Phase II trial of intraperitoneal (IP) MHC unrestricted adoptive cell therapy with TALL-104 cells in patients with ovarian carcinoma (OC) with minim...

Date 20 November 2015
Event ESMO Symposium on Immuno-Oncology 2015
Session Welcome reception and general Poster viewing
Topics Ovarian Cancer
Cancer Immunology and Immunotherapy
Presenter Pier Franco Conte
Citation Annals of Oncology (2015) 26 (suppl_8): 5-14. 10.1093/annonc/mdv514
Authors P.F. Conte1, M. Accoto2, F. Nannipieri2, Z. Baretta3, A. Baldoni1, L. Bonanno3, V. Guarneri1, G. Tasca1, E. Di Liso1, S. Trasciatti2
  • 1Surgery,oncology And Gastroenterology, University of Padova, 35128 - Padova/IT
  • 2Research & Development, Galileo Research srl, 56019 - Pisa/IT
  • 3U.o.oncologia Medica, Istituto Oncologico Veneto IRCCS, 35128 - Padova/IT

Abstract

Background

We are developing an allogeneic cell therapy approach that consists in the administration of a human MHC non-restricted T cell line (TALL-104) that displays cytotoxic activity against a broad range of tumors, while sparing normal cells. Preclinical data has provided evidence that TALL-104 cells inhibit the growth of tumors both in vitro and in vivo. TALL-104 cell line was tested in 3 phase I studies: treatment was well tolerated and some clinical response was observed.

Trial design

This Phase II proof of concept study has been designed to evaluate the efficacy of repeated IP administrations of TALL-104 to patients with OC. The primary endpoint is to evaluate the conversion rate from minimal/microscopic residual disease to pathological complete response (pCR). Secondary objectives are safety, kinetics, immunology and tumor markers. The trial is designed as an open label phase II study at two stages (Simon's design). 24 patients will be screened in order to have 21 patients treated and 18 evaluable patients at the first step. If a conversion to pCR is observed in more than 2 patients, a further 22 patients will be screened to have 19 patients treated and 17 evaluable patients. The objective should be a total number of 35 patients evaluable for efficacy. If we observe > 6 pCR then the treatment will be considered for future trials. Main inclusion criteria are: diagnosis of OC (FIGO stage III-IV) with minimal or microscopical residual disease at 2nd look laparotomy/laparoscopy (microscopic residual disease is defined as positive cytology washing and/or positive biopsies; minimal residual disease is defined as tumor lesions of diameter < 0.5 cm). First line treatment includes Platinum compounds and Paclitaxel. Patients must be not eligible for treatment with Bevacizumab. TALL-104 cells will be administered by IP infusion through a port-cath, at day 1, 3, 5 and 15 of a 30-day course. Three courses will be administered with 5x108 cells/infusion.

The study is being funded by Galileo Research srl, with the contribution of the Tuscan Region POR CREO 2007-2013 – Linea d'intervento 1.1C (TALCO, CUP N. 430896).

Clinical trial identification

EudraCT Number 2013-001005-82 of March 4th, 2013

Disclosure

All authors have declared no conflicts of interest.