Methods of treating acute myeloid leukemia and multiple myeloma using natural killer cells

A natural killer cell and acute myeloid technology, applied in cell culture active agents, biochemical equipment and methods, animal cells, etc., can solve problems such as difficult to maintain tumor targeting and tumor killing ability, and difficult immunotherapy

Pending Publication Date: 2019-06-04
ANTHROGENESIS LLC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Despite the favorable properties of NK cells in killing tumor cells and virus-infected cells, they are still difficult to apply to immunotherapy, mainly due to the difficulty in maintaining their tumor-targeting and tumor-killing abilities during culture and expansion

Method used

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  • Methods of treating acute myeloid leukemia and multiple myeloma using natural killer cells
  • Methods of treating acute myeloid leukemia and multiple myeloma using natural killer cells
  • Methods of treating acute myeloid leukemia and multiple myeloma using natural killer cells

Examples

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Embodiment 1

[0610] 6.1 Example 1: Clinical Study - Acute Myeloid Leukemia

[0611] A phase I, phase I, three-phase infusion of human cord blood-derived, culture-expanded natural killer cell infusions and subcutaneous recombinant human IL-2 (rhIL-2) in adults with relapsed and / or refractory acute myeloid leukemia. Multicenter, open-label, dose-escalation safety study.

[0612] The screening / baseline period was defined as the 21 days from Day -28 to Day -7 prior to three-stage NK cell administration, during which time subjects were assessed for eligibility. The Screening / Baseline period was followed by a 5-day conditioning treatment period consisting of cyclophosphamide (60 mg / kg x 2 days on Days -5 and -4, but omitted if less than 4 months from previous transplant Cyclophosphamide dose on day -4) and fludarabine (25 mg / m 2 ×5 days, commencing on day -6) (study days -6 to -2). If less than four months have passed since the previous transplant, omit the next-day fludarabine.

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Embodiment 2

[0628] Example 2: Clinical Study - Multiple Myeloma

[0629] Human cord blood-derived, culture-expanded three-stage natural killer cell infusion and subcutaneous recombinant human IL-2 (rhIL-2) following autologous stem cell transplantation (ASCT) in adults with multiple myeloma (MM) ) Phase I, multicenter, open-label safety study.

[0630] The primary objective of this study was to evaluate the safety of three-stage NK cell administration after ASCT and to determine the maximum tolerated dose in MM subjects. A secondary objective was to explore potential clinical efficacy up to day 100.

[0631] The maximum tolerated dose of three-phase natural killer cells was evaluated on days 2 and 7 after ASCT and determined on day 14 after ASCT. Three phases of natural killer cells were administered intravenously, followed by a total of six IL-2 injections to support NK cells in the body.

[0632] The primary outcome measures were adverse events and dose-limiting toxicities, ...

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Abstract

Provided herein are methods of treating acute myeloid leukemia (AML) and multiple myeloma (MM) by administering an effective amount of a cell population comprising natural killer cells, wherein the cell population comprising natural killer cells is produced by a three- stage method comprising culturing a population of hematopoietic stem or progenitor cells in media comprising stem cell mobilizingfactors, e.g., three-stage methods of producing NK cells in media comprising stem cell mobilizing factors starting with hematopoietic stem or progenitor cells from cells of the placenta, for example,from placental perfusate (e.g., human placental perfusate) or other tissues, for example, umbilical cord blood or peripheral blood. Further provided herein are methods of using the NK cells produced by the three-stage methods provided herein to suppress the proliferation of acute myeloid leukemia cells. In certain embodiments, the NK cells produced by the three-stage methods described herein are used in combination with IL-2.

Description

[0001] This application claims U.S. Provisional Application No. 62 / 333,186, filed May 7, 2016, U.S. Provisional Application No. 62 / 333,187, filed May 7, 2016, U.S. Provisional Application No. 62 / 415,918, filed November 1, 2016 and the benefit of U.S. Provisional Application No. 62 / 415,954, filed November 1, 2016, each of which is incorporated herein by reference in its entirety. 1. Technical field [0002] Provided herein are methods of treating acute myeloid leukemia (AML) and multiple myeloma (MM) by administering an effective amount of a natural killer cell-containing cell population comprising stem cell A three-stage process for culturing a population of hematopoietic stem or progenitor cells in a medium containing mobilizing factors is produced, for example, from placenta, such as from placental perfusate (e.g., human placental perfusate) or A three-stage approach in which hematopoietic stem or progenitor cells of cells from other tissues (such as umbilical cord blood or ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K35/17A61P35/00C12N5/0783
CPCA61K35/17C12N5/0646A61P35/02A61P35/00A61K38/2013C12N2501/2302A61K9/0019C12N5/0647C12N2501/125C12N2501/91C12N2501/999C12N2501/145C12N2501/50C12N2501/26C12N2501/2315C12N2501/2307C12N2501/2306C12N2501/22C12N5/0638C12N2506/11
Inventor S·A·菲施科弗U·赫兹博格康琳B·墨菲A·诺德伯格V·沃斯基纳里安-伯塞K·威尔逊张晓奎H·迈因特M·侯赛因
Owner ANTHROGENESIS LLC
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