Bispecific monoclonal antibodies, with a dual specificity for tumor as
sociated antigens on target cells and for surface markers on immune ef
fector cells, have been shown (in vitro) to be effective in directing
and triggering effector cells to kill target cells resulting in target
cell lysis. Bispecific monoclonal antibodies (BsAb) against the CD3 a
ntigen on T cells and the CD19 antigen on B cell were developed. Data
obtained by in vitro experiments might indicate that clinical response
s in BsAb immunotherapy, will only be obtained in patients with minima
l tumor load and may need additional T cell stimulation via cytokines
such as IL-2. Although these experiments have shown us their limitatio
ns, they also include the promise of BsAb-directed immunotherapy in B
cell malignancy as further demonstrated during a Phase I trail, showin
g little toxicity. Clearly, much remains to be done before this BsAb i
s routinely used for therapy, but, the results presented show that the
CD3xCD19 BsAb has a potential as a therapeutic agent in B cell malign
ancy. This report describes the experiments performed to test a new im
munotherapeutic approach for the treatment of B cell malignancy. Bispe
cific antibodies are described that can target cytotoxic T cells to tu
mor cells and elicit a cytolytic action towards these cancer cells.