CPC A61K 9/0019 (2013.01) [A61K 38/2013 (2013.01); A61K 39/4611 (2023.05); A61K 39/4644 (2023.05); A61P 35/00 (2018.01); C12N 5/0638 (2013.01); C07K 16/2809 (2013.01); C12N 2501/2302 (2013.01); C12N 2502/11 (2013.01)] | 15 Claims |
1. A method of administering tumor infiltrating lymphocytes (TILs) to a subject with endometrial cancer, wherein the method comprises:
(a) adding into a closed system a plurality of tumor fragments comprising a first population of TILs obtained by processing a sample of tumor tissue resected from the subject with endometrial cancer into the plurality of tumor fragments;
(b) performing a first expansion by culturing the first population of TILs in a cell culture medium comprising IL-2 to produce a second population of TILs, wherein the first expansion is performed in a closed container providing a first gas-permeable surface area, wherein the first expansion is performed for about 3-11 days to obtain the second population of TILs, and wherein the transition from step (a) to step (b) occurs without opening the system;
(c) performing a second expansion by supplementing the cell culture medium of the second population of TILs with additional IL-2, OKT-3, and antigen presenting cells (APCs), to produce a third population of TILs, wherein the second expansion is performed for about 7-11 days to obtain the third population of TILs, wherein the second expansion is performed in a closed container providing a second gas-permeable surface area, and wherein the transition from step (b) to step (c) occurs without opening the system;
(d) harvesting the third population of TILs obtained from step (c), wherein the transition from step (c) to step (d) occurs without opening the system;
(e) transferring the harvested third TIL population from step (d) to an infusion bag, wherein the transfer from step (d) to (e) occurs without opening the system;
(f) cryopreserving the infusion bag comprising the harvested TIL population from step (e) using a cryopreservation process; and
(g) administering a therapeutically effective dosage of the third population of TILs from the infusion bag in step (f) to the subject.
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