MEASURING CIRCULATING THERAPEUTIC ANTIBODY, ANTIGEN AND ANTIGEN/ANTIBODY COMPLEXES USING ELISA ASSAYS
The present invention relates to the field of immunology and hyperproliferative diseases. More specifically, the present invention relates to a method of detecting and monitoring therapeutic antibody:antigen complex, soluble antigen and soluble therapeutic antibody, wherein a patient has undergone at least one course of immunotherapy. Yet further, levels of therapeutic antibody:antigen complexes, soluble antigens or soluble therapeutic antibodies may be measured and used to stage or monitor a hyperproliferative disease.
1 .- 3 . (canceled)
4 . A method of an immunotherapy comprising administering to a patient a therapeutic antibody and detecting the presence of a circulating antibody:antigen complex.
5 . The method of claim 4 , wherein the antibody binds to a soluble antigen.
6 . The method of claim 5 , wherein the antigen is shed from the cell surface.
7 . The method of claim 5 , wherein the antigen is CD20, CD52 or CD33.
8 . (canceled)
9 . A method of detecting a therapeutic antibody:antigen complex comprising:
obtaining a sample from a patient, wherein the patient has undergone a course of immunotherapy with a therapeutic antibody in which the therapeutic antibody binds to a soluble circulating target antigen forming the complex;
contacting the sample with a first monoclonal antibody, wherein the antibody captures the complex;
contacting the complex with a labeled second antibody; and
measuring the labeled complex.
10 .- 12 . (canceled)
13 . The method of claim 9 , wherein the first monoclonal antibody is anti-CD20, anti-CD52 or anti-CD33.
14 . The method of claim 9 , wherein the therapeutic antibodies are anti-CD20, anti-CD52 or anti-CD33.
15 . The method of claim 14 , wherein the therapeutic antibody is Rituximab.
16 . The method of claim 14 , wherein the therapeutic antibody is Campath-1H.
17 . The method of claim 14 , wherein the therapeutic antibody is Mylotarg.
18 .- 19 . (canceled)
20 . The method of claim 4 , wherein the therapeutic antibody is anti-CD20, anti-CD52 or anti-CD33.
21 . The method of claim 20 , wherein the therapeutic antibody is Rituximab.
22 . The method of claim 20 , wherein the therapeutic antibody is Campath-1H.
23 . The method of claim 20 , wherein the therapeutic antibody is Mylotarg.
24 .- 32 . (canceled)
33 . A method of monitoring an autoimmune disease comprising measuring a therapeutic antibody:antigen complex in the patient serum.
34 . The method of claim 33 , wherein the therapeutic antibody is anti-CD52.
35 . The method of claim 34 , wherein the therapeutic anti-CD52 is Campath-1H.
36 . The method of claim 33 further comprising measuring a second therapeutic antibody:antigen complex.
37 . The method of claim 36 , wherein the second therapeutic antibody is anti-CD20.
38 .- 73 . (canceled)