Means and Methods for Treating Tumorous Diseases

A method for treating or ameliorating relapse and/or recurrence of indolent or aggressive B cell non-Hodgkin lymphoma (B NHL) or relapse and/or recurrence of B cell leukemia in a subject suffering from relapsed and/or recurrent B NHL and/or B cell leukemia, the method comprising administering to the subject

• (a) a pharmaceutical composition comprising a bispecific single chain antibody comprising the amino acid sequence set forth in SEQ ID NO:
• 2;
• and
• (b) a chemotherapy, a radiation therapy, a hormonal therapy, and/or a biological or immunotherapy,
• wherein the bispecific single chain antibody is administered in a daily dose over at least six hours by continuous intravenous infusion for at least four weeks, wherein a lower daily dose of less than 10 μg to 80 μg per square meter subject body surface area of the bispecific single chain antibody is administered as an initial dose followed by a higher maintenance daily dose.

A method for treating or ameliorating indolent or aggressive B cell non-Hodgkin lymphoma (B NHL) or B cell leukemia in a subject, the method comprising administering to the subject

• (a) a pharmaceutical composition comprising a bispecific single chain antibody;
• and
• (b) a chemotherapy, a radiation therapy, a hormonal therapy, and/or a biological or immunotherapy,
• wherein the bispecific single chain antibody construct comprises 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 administered for at least 1 week in a daily dose of 10 μg to 80 μg per square meter subject body surface area and wherein the daily dose is administered over at least 6 hours, and
• wherein each VL and VH region comprises a CDR1, CDR2, and CDR3 region.