15353-j-veluchamy

16 | Chapter 1 Phase I (NCT00586690) Rizzieri et al (2010) ref 55 Lymphoma (n=30) 3-6/6 HLA-matched haploidentical NK- cell infusion, 6 to 8 weeks post haplo- HSCT from the same donor PBNK-cells from haploidentical donors. * Only CD56 selected Phase I (NCT00569283) Yoon et al (2010) ref 54 AML (n=12) MDS (n=2) HLA mismatched HSCT followed by allo NK-cell infusion from the same donor Ex vivo expanded, differentiated and activated CD34+ progenitor-cells (PB-derived) from haploidentical donors. Culture duration: 21 days with FLt3, IL-7 and hydrocortisone followed by 21 days with IL-15, IL-21 and hydrocortisone (BB-IND-11347) Shi et al (2008) ref 53 MM (n=10) Conditioning with Flu/Dex/Mel followed by haplo- KIR-ligand mismatched NK-cell infusion on day 0 and day +2; IL-2 therapy daily (11x) starting on day +1 after NK-cell infusion; auto-HSCT on day +14 Ex vivo expanded and activated PBNK-cells from haploidentical donors. Culture duration: o/n with IL-2 (pts 1-5) and brief incubation with IL-2 and anti-CD3 beads (pts 5-10). Pilot study Koehl et al (2004) ref 52 AML (n=1) ALL (n=2) Haplo-HSCT followed by KIR mismatched NK-cell infusion on day +1 or +2 post HSCT and additional infusions every 4-6 weeks; IL-2 therapy +2 days post HSCT, every second day for 2-4 weeks Ex vivo expanded and activated PBNK-cells from haploidentical donors. Culture duration :>12 days with IL-2. *CD3 depleted and CD56 selected (in 3 infusions) Pilot study Passweg et al (2004) ref 51 AML (n=4), CML (n=1) Haplo-HSCT followed by NK-DLI from the same donor 3-12 months post HSCT PBNK-cells from haploidentical donors. *CD3 depleted and CD56 selected Abbreviations Malignancies: Central Nervous System (CNS), Myeloproliferative Disorders (MPD), Lymphoproliferative Disorder (LPD), Multiple Myeloma (MM), Myelodysplastic Syndromes (MDS), Myelodysplastic Neoplasms (MDN) Myeloproliferative Neoplasms (MPN), Acute Myeloid Leukemia (AML), Lymphoblastic Leukemia-Lymphoma (LBLL), Acute Lymphoblastic Leukemia (ALL), Neuroblastoma (NB), Rhabdomyosarcoma (RMS), Chronic Myelogenous Leukemia (CML), Non- Hodgkin’s Lymphoma (NHL), Mantle Cell Lymphoma (MCL), Diffuse Large B Cell Lymphoma (DLBCL), Follicular Lymphoma (FL), Anaplastic Large Cell Lymphoma (ALCL), Hodgkin’s Lymphoma (HL), Renal Cell Cancer (RCC), Small Cell Lung Cancer (SCLC), Chronic Lymphocytic Leukemia (CLL), Hepatocellular Carcinoma (HCC), Primitive Neuroectodermal Tumor (PNET), Adrenal Cortical Carcinoma (ACC), Mantle Cell Lymphoma (MCL), Diffuse Large B Cell Lymphoma (DLBCL), Anaplastic Large Cell Lymphoma (ALCL), Ewing sarcoma (EWS), Desmoplastic Small Round Cell Tumor (DSRCT). Study Malignancy Clinical Trial design Culture method*