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US 11,304,980 B2Granted
Restimulation of cryopreserved tumor infiltrating lymphocytes
AssigneeIovance Biotherapeutics, Inc.
InventorsIan Frank, Michael T. Lotze
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Abstract
The present disclosure provides methods for re-stimulating TIL populations that lead to improved phenotype and increased metabolic health of the TILs and provides methods of assaying for TIL populations to determine suitability for more efficacious infusion after re-stimulation.
Claims20
A cryopreserved tumor infiltrating lymphocyte (TIL) composition comprising a therapeutic population of TILs, wherein the cryopreserved TIL composition is produced by the method comprising:
- (a) performing a first expansion by (i) thawing a cryopreserved tumor digest comprising a first population of TILs from a tumor that was resected from a subject, digested after the resection, and cryopreserved after the digestion, and (ii) culturing the first population of TILs in a cell culture medium comprising IL-2 to produce a second population of TILs, wherein the tumor digest was prepared by incubating a sample of the tumor that was resected from the subject in an enzymatic media;
- (b) 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 third population of TILs is a therapeutic population of TILs, and wherein the second expansion is performed for about 7 to 14 days in order to obtain the therapeutic population of TILs;
- (c) harvesting the therapeutic population of TILs obtained from step (b);
- (d) admixing the harvested therapeutic population of TILs from step (c) with a cryopreservation media to form an admixture;
- and
- (e) cryopreserving the admixture from step (d) using a cryopreservation process to produce a cryopreserved TIL composition.
3 more elements
Dependencies are inferred from the claim text.