Means and methods for the treament of tumorous diseases

A method for the prevention, treatment or amelioration of indolent or aggressive B cell non-Hodgkin lymphoma (B NHL) or 13 cell leukemia, the method comprising the administration of a pharmaceutical composition comprising a bispecific single chain antibody construct to a subject in the need thereof, said bispecific single chain antibody construct comprising binding domains specific for human CD3 and human CD19, wherein the corresponding variable heavy chain regions (VH) and the corresponding variable light chain regions (VL) regions are arranged, from N-terminus to C-terminus, in the order,

• VL(CD19)-VH(CD19)-VH(CD3)-VL(CD3),
• VH(CD19)-VL(CD19)-VH(CD3)-VL(CD3),
• VH(CD3)-VL(CD3)-VH(CD19)-VL(CD19) or
• VH(CD3)-VL(CD3)-VL(CD19)-VH(CD19).
• wherein the bispecific single chain antibody construct is to be administered for at least 1 week in a daily dose of 10 μg to 80 μg per square meter patient body surface area and wherein the daily dose is to be administered over at least 6 h.

A kit comprising a pharmaceutical composition for the prevention, treatment or amelioration of indolent or aggressive 13 cell non-Hodgkin lymphoma (B NHL) or B cell leukemia in humans, the pharmaceutical composition comprising a pharmaceutically active bispecific single chain antibody construct comprising binding domains specific for human CD3 and human CD19, wherein the corresponding variable heavy chain regions (VH) and the corresponding variable light chain regions (VL) regions are arranged, from N-terminus to C-terminus, in the order,

• VL(CD19)-VH(CD19)-VH(CD3)-VL(CD3),
• VH(CD19)-VL(CD19)-VH(CD3)-VL(CD3),
• VH(CD3)-VL(CD3)-VH(CD19)-VL(CD19) or
• VH(CD3)-VL(CD3)-VL(CD19)-VH(CD19)
• and an instruction sheet in which the administration scheme for the bispecific single chain antibody construct is described to comprise an administration for at least 1 week in a daily dose of 10 μg to 80 μg per square meter patient body surface area and whereby said daily dose is to be administered over at least 6 h.

A kit for use in the prevention, treatment or amelioration of indolent or aggressive B cell non-Hodgkin lymphoma (B NHL) or B cell leukemia in humans, according to a regimen of at least one week comprising the administration of a bispecific single chain antibody construct comprising binding domains specific for human CD3 and human CD19, wherein the corresponding variable heavy chain regions (VH) and the corresponding variable light chain regions (VI) regions are arranged, from N-terminus to C-terminus, in the order,

• VL(CD19)-VH(CD19)-VH(CD3)-VL(CD3),
• VH(CD19)-VL(CD19)-VH(CD3)-VL(CD3),
• VH(CD3)-VL(CD3)-VH(CD19)-VL(CD19) or
• VH(CD3)-VL(CD3)-VL(CD19)-VH(CD19)
• wherein said bispecific single chain antibody construct is to be administered for at least 1 week in a daily dose of 10 μg to 80 μg per square meter patient body surface area and wherein said daily dose is to be administered over at least 6 h, and wherein said kit contains the following components:
• (a) at least 7 individual daily doses of from 140 μg to 320 μg of said pharmaceutical active bispecific single chain antibody construct;
• and
• (b) a means for having the components arranged in a way to facilitate compliance with the regimen.