Abstract: The present invention relates to a PPS for use in the amelioration, treatment or prophylaxis of neurological adverse events caused by a CD3 binding domain. Kits comprising a PPS, a CD3 binding domain and instructions for use which indicate that the PPS is to be employed for the treatment amelioration and/or prophylaxis of neurological adverse events caused by said CD3 binding domain, are also disclosed.

Abstract: The present invention relates in essence to a compound which decreases or inhibits the binding of mammalian T-cells to mammalian endothelial cells for use in a method of prophylaxis and/or amelioration and/or treatment of clinical adverse events caused by therapy which comprises re-directing of T-cells against target cells in a patient. Methods of treatment of patients having or being at risk of clinical adverse events caused by therapy which comprises re-directing of T-cells against target cells are also contemplated.

Abstract: The present invention relates to a method for assessing (analyzing) the risk of potential adverse effects for a human patient mediated by the administration of a CD19xCD3 bispecific antibody to said patient comprising determining the ratio of B cells to T cells of said patient, wherein a ratio of about 1:5 or lower is indicative for a risk of potential adverse effects for said patient or determining the total B cell count of said patient, wherein a total B cell count of less than about 50 B cells per microliter of peripheral blood is indicative for a risk of potential adverse effects for said patient.

Abstract: The present invention provides means and methods for treating diffuse large B cell lymphoma (DLBCL). Specifically, a bispecific CD19×CD3 antibody which engages T cells via its CD3 binding portion and concomitantly binds to CD19 on the surface of in particular, lymphoma cells via its CD19 binding portion (i.e. a bispecific T cell engager, “BiTE”) is administered for use in the treatment of tumorous mass of lymophoreticular tissue and/or extranodal lymphoma caused by DLBCL in a patient.

Abstract: The present invention relates to a glucocorticoid (GC) for use in the amelioration, treatment or prophylaxis of neurological/psychiatric adverse events caused by a CD3 binding domain. Kits comprising a GC, a CD3 binding domain and instructions for use which indicate that the GC is to be employed for the treatment amelioration and/or prophylaxis of neurological adverse events caused by said CD3 binding domain, are also disclosed.

Abstract: The present invention relates to a method for assessing (analyzing) the risk of potential adverse effects for a human patient mediated by the administration of a CD19×CD3 bispecific antibody to said patient comprising determining the ratio of B cells to T cells of said patient, wherein a ratio of about 1:5 or lower is indicative for a risk of potential adverse effects for said patient. Accordingly, the present invention relates a method (dosage regimen) for administering a CD19×CD3 bispecific antibody to a human patient having a B:T cell ratio of about 1:5 or lower, comprising (a) administering a first dose of said antibody for a first period of time; and consecutively (b) administering a second dose of said antibody for a second period of time, wherein said second dose exceeds said first dose.In some embodiments, a third dose of said antibody is administered for a third period of time.