JP-2022513691-A5 -

Dates

Publication Date

20221205

Application Date

20191126

Description

The foregoing description and examples detail certain embodiments of the present invention and describe the best mode intended by the inventors. However, it will be understood that, no matter how detailed the foregoing may appear in text, the present invention can be carried out in many ways, and the present invention should be construed in accordance with the appended claims and any equivalents thereof. Another aspect of the present invention may be as follows: [1] A method for treating multiple myeloma in a subject, comprising administering to the subject at least one dose of allogeneic chimeric antigen receptor (CAR)-T cells (BCMA CAR-T cells) containing anti-human BCMA CAR, wherein the at least one dose is approximately 7 × 10^6 cells/dose to approximately 480 × 10^6 cells/dose. [2] The method according to [1], wherein the weight of the subject is 50 kg or more, and the method comprises administering at least one dose of BCMA CAR-T cells, wherein the dose is in the range of about 20 × 10^6 cells/dose to about 480 × 10^6 cells/dose. [3] The method according to [2], wherein the at least one dose is approximately 20 × 10^6 cells/dose, approximately 40 × 10^6 cells/dose, approximately 120 × 10^6 cells/dose, approximately 360 × 10^6 cells/dose, or approximately 480 × 10^6 cells/dose. [4] The method according to [2], wherein the at least one dose is approximately 20 × 10^6 cells/dose to approximately 40 × 10^6 cells/dose, approximately 40 × 10^6 cells/dose to approximately 120 × 10^6 cells/dose, approximately 120 × 10^6 cells/dose to approximately 360 × 10^6 cells/dose, or approximately 360 × 10^6 cells/dose to approximately 480 × 10^6 cells/dose. [5] The method according to [1], wherein the weight of the subject is less than 50 kg, and the method comprises administering at least one dose of BCMA CAR-T cells, wherein the dose is in the range of about 7 × 10^6 cells/dose to about 360 × 10^6 cells/dose. [6] The method according to [5], wherein the at least one dose is approximately 7 × 10^6 cells/dose, approximately 14 × 10^6 cells/dose, approximately 20 × 10^6 cells/dose, approximately 80 × 10^6 cells/dose, approximately 240 × 10^6 cells/dose, or approximately 360 × 10^6 cells/dose. [7] The method according to [5], wherein the at least one dose is approximately 7 × 10^6 or 14 × 10^6 cells/dose to approximately 20 × 10^6 cells/dose, approximately 20 × 10^6 cells/dose to approximately 80 × 10^6 cells/dose, approximately 80 × 10^6 cells/dose to approximately 240 × 10^6 cells/dose, or approximately 240 × 10^6 cells/dose to approximately 360 × 10^6 cells/dose. [8] The method according to [1], wherein the weight of the subject is greater than 50 kg, and the method comprises administering at least one dose of BCMA CAR-T cells, wherein the dose is in the range of about 20 × 10^6 cells/dose to about 480 × 10^6 cells/dose. [9] The method according to [8], wherein the at least one dose is approximately 20 × 10^6 cells/dose, approximately 40 × 10^6 cells/dose, approximately 160 × 10^6 cells/dose, approximately 240 × 10^6 cells/dose, approximately 320 × 10^6 cells/dose, or approximately 480 × 10^6 cells/dose. [10] The method according to [8], wherein the at least one dose is approximately 20 × 10^6 cells/dose to approximately 40 × 10^6 cells/dose, approximately 40 × 10^6 cells/dose to approximately 160 × 10^6 cells/dose, approximately 160 × 10^6 cells/dose to approximately 240 × 10^6 cells/dose, approximately 240 × 10^6 cells/dose to approximately 320 × 10^6 cells/dose, approximately 160 × 10^6 cells/dose to approximately 320 × 10^6 cells/dose, or approximately 320 × 10^6 cells/dose to approximately 480 × 10^6 cells/dose. [11] The method according to [1], wherein the weight of the subject is 50 kg or less, and the method comprises administering at least one dose of BCMA CAR-T cells, wherein the dose is in the range of about 14 × 10^6 cells/dose to about 320 × 10^6 cells/dose. [12] The method according to [11], wherein the at least one dose is approximately 14 × 10^6 cells/dose, approximately 20 × 10^6 cells/dose, approximately 80 × 10^6 cells/dose, approximately 160 × 10^6 cells/dose, approximately 200 × 10^6 cells/dose, or approximately 320 × 10^6 cells/dose. [13] The method according to [12], wherein the at least one dose is approximately 14 × 10^6 cells/dose to approximately 20 × 10^6 cells/dose, approximately 20 × 10^6 cells/dose to approximately 80 × 10^6 cells/dose, approximately 80 × 10^6 cells/dose to approximately 200 × 10^6 cells/dose, approximately 80 × 10^6 cells/dose to approximately 160 × 10^6 cells/dose, approximately 160 × 10^6 cells/dose to approximately 200 × 10^6 cells/dose, or approximately 200 × 10^6 cells/dose to approximately 320 × 10^6 cells/dose. [14] The method according to any one of the above [1] to [13], wherein the multiple myeloma is a refractory multiple myeloma. [15] The method according to any one of the above [1] to [14], wherein the multiple myeloma is recurrent multiple myeloma. [16] Th