Extrait

The proposed study will test the feasibility of generating donor-derived cytomegalo virus (CMV)-specific T cells via the ex vivo introduction of a CMV-specific T cell receptor using a GMP grade retroviral vector. It will also determine the safety, toxicity (side effects) and efficacy of CMV TCR-transduced T cells used for the pre-emptive treatment of CMV reactivation following HLA-matched sibling Allo-Haematopoietic Stem Cell Transplantation. Primary Objectives: (i) Evaluate the feasibility of retroviral-mediated TCR gene transfer to generate CMV-specific T cells from CMV seronegative donors; (ii) Evaluate the safety, toxicity and side effects of pre-emptive CMV TCR-transduced donor-derived T cells for immunotherapy after Allo-HSCT, where donors are CMV seronegative. Primary Endpoints: (i) Document transduction efficiency and TCR expression on TCR-transduced T cells; (ii) Identify organ toxicities and other side effects. We propose that CMV TCR-transduced T cells, generated from

Critère d'inclusion

• CMV reactivation/infection in post allogeneic haematopoietic stem cell transplant recipients. Allo-HSCT being performed for underlying haematological malignancy (eg, AML, ALL, NHL, Hodgkin Lymphoma, etc)

Liens

• ictrp
• euctr