US 11,730,761 B2
Combination immune therapy and cytokine control therapy for cancer treatment
Shai Novik, Ramat Hasharon (IL); and Dror Mevorach, Jerusalem (IL)
Assigned to Enlivex Therapeutics RDO Ltd, Nes-Ziona (IL)
Appl. No. 16/76,026
Filed by Enlivex Therapeutics RDO Ltd, Nes-Ziona (IL)
PCT Filed Feb. 15, 2017, PCT No. PCT/IL2017/050196
§ 371(c)(1), (2) Date Aug. 7, 2018,
PCT Pub. No. WO2017/141243, PCT Pub. Date Aug. 24, 2017.
Claims priority of provisional application 62/296,622, filed on Feb. 18, 2016.
Claims priority of provisional application 62/370,741, filed on Aug. 4, 2016.
Prior Publication US 2019/0175649 A1, Jun. 13, 2019
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 48/00 (2006.01); C12N 5/00 (2006.01); A61K 35/17 (2015.01); A61K 39/00 (2006.01); C07K 16/28 (2006.01); C12N 5/0783 (2010.01); A61P 35/00 (2006.01); A01K 67/00 (2006.01)
CPC A61K 35/17 (2013.01) [A61K 39/0011 (2013.01); A61P 35/00 (2018.01); C07K 16/2803 (2013.01); C12N 5/0636 (2013.01); C12N 5/0638 (2013.01); A61K 2039/5158 (2013.01); C07K 2317/622 (2013.01); C07K 2319/03 (2013.01); C07K 2319/33 (2013.01); C12N 2510/00 (2013.01)] 19 Claims
 
1. A method of maintaining or increasing the proliferation rate of chimeric antigen receptor-expressing T-cells (CAR T-cell) and maintaining or increasing IL-2 level during CAR T-cell cancer therapy, the method comprising a step of administering to a human subject undergoing autologous or allogeneic CAR T-cell cancer therapy a composition comprising a preparation of human autologous or allogeneic mononuclear-enriched early apoptotic cells, or a supernatant of human autologous or allogeneic mononuclear-enriched early apoptotic cells, wherein said preparation of human autologous or allogeneic mononuclear-enriched early apoptotic cells is ≥40% AnnexinV+and ≤15% propidium iodide+, and wherein said human autologous or allogeneic mononuclear-enriched early apoptotic cells are peripheral blood mononuclear cells, wherein said proliferation rate of CAR T-cells and said IL-2 level are maintained or increased in the subject compared with a subject undergoing autologous or allogeneic CAR T-cell cancer therapy and not administered said preparation of human autologous or allogeneic mononuclear-enriched early apoptotic cells, or said supernatant of human autologous or allogeneic mononuclear-enriched early apoptotic cells.