15353-j-veluchamy

20 | Chapter 1 Phase I (BB-IND-14560) Szmania et al (2015) ref 79 MM (n=8) Conditioning with Bor (+/- Cy/ Flu/Dex) followed by fresh haplo-(n=6) or cryopreserved auto (n=2) NK cells. Ex vivo expanded and activated PBNK cells from haploidentical (fresh) and autologous (cryopreserved) donors. Culture: 8-9 days with K562-mb15-41BBL stimulator cells and IL-2 Phase II (NCT00274846) Bachanova et al (2014) ref 80 AML (n=57) Conditioning with Cy/Flu; IL2DT in cohort 3 followed by haploidentical NK-cell infusion 1 day later; IL-2 therapy (14x, daily) Ex vivo expanded and activated PBNK-cells from haploidentical donors. Culture duration: o/n with IL-2. *CD3 depleted (cohort 1) or CD3 depleted/CD56 selected (cohort 2) or CD3/CD19 depleted (cohort 3) Tonn et al (2013) ref 50 Solid tumors/ sarcoma (n=12) Leukemia/ lymphoma (n=2) Pre-treatment with mPred following NK-92 cell infusion Ex vivo expanded and activated allogeneic NK-92 cells. Culture duration :100-300h with IL-2. *no selection Pilot study (NCT00799799) Curti et al (2011) ref 63 AML (n=13) Conditioning with Cy/ Flu followed by KIR ligand mismatched NK-cell infusion; IL-2 therapy (3x weekly for 2 weeks) PBNK-cells from haploidentical donors. *CD3 depleted and CD56 selected Phase II (BB-IND 8847) Geller et al (2011) ref 40 Refractory Metastatic Breast Cancer (n=14) Ovarian Cancer (n=6) Conditioning with Cy/Flu with or without TBI followed by allogeneic NK-cell infusion; IL-2 therapy (3x weekly for 2 weeks) Ex vivo expanded and activated PBNK-cells from haploidentical donors. Culture duration: o/n with IL-2 Pilot study Bachanova et al (2010) ref 62 B-cell NHL (n=6) Conditioning with Cy/Flu and mAb (Rituximab, 4x) before and after haplo NK-cell infusion followed by IL-2 therapy (6x, every other day) Ex vivo expanded and activated PBNK-cells from haploidentical donors. Culture duration :8-16h with IL-2 Pilot study NKAML Rubnitz et al (2010) ref 61 AML (n=10) Conditioning with Cy/Flu followed by KIR mismatched NK-cell infusion; IL-2 therapy (6x) starting 1 day before and after NK-cell infusion PBNK-cells from haploidentical donors. *CD3 depleted and CD56 selected Phase I (EudraCT number: 2005-005125-58) I liopoulou et al (2010) ref 60 Non-SCLC (n=16) Haploidentical NK cell infusion after chemotherapy Ex vivo expanded and activated PBNK-cells from haploidentical donors. Culture duration :21-23 days with IL-15 followed by 1h with IL-15 and hydrocortisone. *Only CD56 selected Study Malignancy Clinical Trial design Culture method*