Claims for Patent: 7,993,638

Summary for Patent: 7,993,638

Title:	Cancer treatment combining lymphodepleting agent with CTLs and cytokines
Abstract:	In a cancer treatment combining cell therapy with chemotherapy, autologous CD8.sup.+ T cells are obtained from a patient, activated ex vivo by contacting them with xenogenic antigen presenting cells loaded with selected peptide antigen, thereby generating antigen-specific activated cytotoxic T lymphocytes. Such activated CTLs are administered to the patient in conjunction with a lymphodepletion and CTL maintenance regimen comprising a non-myeloblative but lymphdepleting agent, such as cladribine or denileukin diftitox, and interleukin-2 and interferon-.alpha.-2b stimulatory cytokines.
Inventor(s):	Cai; Zeling (San Diego, CA), Moriarty; Ann (Poway, CA), Peterson; Per A. (Rancho Santa Fe, CA), Richards; Jon M. (Glenview, IL)
Assignee:	Janssen Pharmaceutica NV (BE)
Application Number:	12/281,197
Patent Claims:	1. A method for treating a subject in need of treatment for cancer, comprising: (a) obtaining naive CD8+T cells from the subject; (b) contacting the naive CD8+T cells ex vivo with xenogenic antigen presenting cells loaded with one or more peptide antigens, thereby generating activated CTLs that target cells expressing said one or more peptide antigens; (c) administering to the subject the activated CTLs; (d) administering to the subject at least two cytokines that effect CTL persistence; and (e) administering to the subject a lymphodepleting agent selected from the group consisting of cladribine and denileukin diftitox. 2. A method as defined in claim 1, wherein said at said at least two cytokines comprise interferon-.alpha.-2b and interleukin-2. 3. A method as defined in claim 2, wherein said one or more peptide antigens comprise an amino acid sequence derived from a protein selected from gp100, tyrosinase, and MART-1. 4. A method as defined in claim 1, wherein said one or more peptide antigens consists of peptide antigens derived from human gp100, tyrosinase, and MART-1 proteins. 5. A method as defined in claim 1, wherein each of said one or more peptide antigens is selected from the group consisting of YMNGTMSQV (SEQ ID NO:1), YMDGTMSQV (SEQ ID NO:2), AAGIGILTV (SEQ ID NO:3), ITDQVPFSV (SEQ ID NO:4), YLEPGPVTA (SEQ ID NO:5), and KTWGQYWQV (SEQ ID NO:6). 6. A method as defined in claim 5, wherein said cancer is a melanoma. 7. A method as defined in claim 1, wherein the administration of the lymphodepleting agent begins before the administration of the activated CTLs.

Details for Patent 7,993,638

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Eisai, Incorporated	ONTAK	denileukin diftitox	Injection	103767	02/05/1999		2026-03-01