The present invention provides, among other things, devices, kits, apparatus, and methods for rapid homogenous cell staining and imaging. Particularly, in some embodiments, the present invention can immunochemically stain a cell or a tissue in less than 60 seconds without washing. In some embodiments, the present invention stains and observers analyte (protein or nucleic acid) inside a cell in 60 seconds without wash.

The use of differentiation marker CD89 for the detection of cellular reservoirs of a mammalian immunodeficiency virus. Also the use of the differentiation marker CD89 for making a prognosis, diagnosing a remission, and evaluating the efficacy of treatment of the mammalian immunodeficiency. A multi-specific antibody that recognizes both at least one epitope of CD89 and at least one characteristic of the lymphocyte cells, a composition including the antibody, and the use of the antibody for treatment.

The object of the present invention is to provide a method for identifying a patient with malignant tumor on which the effect of an immune checkpoint inhibitor can be more expected, and agents for suppressing the progression of, suppressing the recurrence of, and/or treating malignant tumor, characterized by prescriptions based on those.

The present invention can provide agents for suppressing the progression of, suppressing the recurrence of, and/or treating malignant tumor, characterized by prescriptions based on identifying a patient with a malignant tumor on which the effect of an immune checkpoint inhibitor can be more expected, by analyzing the evaluation items consisting of combinations such as the PD-1 expression intensity, the percentage of the number of PD-1 expressing cells and the like in Treg cells and CD8.sup.+ T cells in tumor tissue or blood.

There is provided methods of determining tuberculosis (TB) infection status in an individual comprising: (i) providing a sample comprising T-cells; (ii) exposing the sample of (i) to one or more TB antigens; (iii) identifying T-cells in the sample that are CD4 positive and (a) secrete TNF-α without secreting IFN-γ; or (b) secrete IFN-γ without secreting TNF-α; (iv) identifying those cells of (iii) which are also CCR7 and, CD127 negative; and optionally (v) calculating the cells identified in (iv) as a percentage of those identified in (iii); wherein the identification of cells in (iv) and/or the percentage of T-cells calculated in (v) correlates to TB infection status of the individual, and wherein steps (iii) and (iv) can be carried out either sequentially or simultaneously. There are also provided compositions and kits for use in such methods.

The invention provides compositions, methods, and vaccines that may stimulate the immune system and that may be used for treating malignancies associated with overexpression of the HER3 protein. Such compositions include epitopes of the HER3 protein.

The present disclosure provides methods for measuring the number of CD4+ OX40+ Foxp3+ lymphocytes in a sample containing cancer cells and lymphocytes obtained from a subject by labeling lymphocytes that show CD4 expression in the sample, then labeling lymphocytes that show OX40 expression in the sample, then labeling lymphocytes that show Foxp3 expression in the sample, then measuring the number of CD4+ OX40+ Foxp3+ lymphocytes in the sample. Further provided are methods for determining the prognosis of a subject, predicting responsiveness of a subject having cancer to an OX40 agonist treatment, and methods for treating or delaying progression of cancer based on the number of CD4+ OX40+ Foxp3+ lymphocytes in a sample.

Provided are methods and articles of manufacture for use with cell therapy for the treatment of diseases or conditions, e.g., cancer, including for predicting likelihood of the subject responding to a therapy, such as a cell therapy, e.g., a chimeric antigen receptor (CAR) T cell therapy. In some aspects, the predicting is based on detecting certain biomarkers of immune cells associated with and/or that correlate with response following administration of the therapy. The methods generally involve detecting a marker by assaying a biological sample from a subject that is a candidate for treatment, optionally with a cell therapy, to determine if the subject is likely to respond to the therapy. The present disclosure also provides methods for treating a subject having a disease or condition, in some cases involving administration of the cell therapy, based on assessment the biomarker. Also provided herein are reagents and kits for performing the methods.

The present invention pertains to polynucleotides that encode CDR3 in TCR-[alpha] and TCR-[beta] chain genes of CD4.sup.+ helper T-cells that are specific to WT1 helper peptides having an amino acid sequence represented by SEQ ID NO: 123. The present invention further pertains to the peptides encoded by said polynucleotides. The present invention further pertains to CD4.sup.+ T cells into which TCR genes that contain said polynucleotides have been introduced, the induction of WT1-specific cytotoxic T-lymphocytes (CTLs) using the CD4.sup.+ T-cells, the treatment of cancer, etc.

The present invention provides a reagent composition for detection of a non-hematopoietic tumor and use thereof. Said reagent composition includes three sets of antibodies, with the first set of antibodies including an anti-CD9 antibody, an anti-GD2 antibody, an anti-CD3 antibody, an anti-CD4 antibody, an anti-CD56 antibody, an anti-CD36 antibody, an anti-CD81, and an anti-CD45 antibody; the second set of antibodies including an anti-HLA-ABC antibody, an anti-CD38 antibody, an anti-CD19 antibody, an anti-CD56 antibody, an anti-CD36 antibody, an anti-CD7 antibody, and an anti-CD45 antibody; the third set of antibodies including anti-cytoplasmic cytokeratin antibodies; wherein the first set of antibodies and the second set of antibodies are respectively used for samples in separate tubes, and the third set of antibodies is used for the sample in the same tube as the second set of antibodies. The reagent composition of the present invention can be applied for flow cytometry screening, diagnosis and/or follow-up detection of a non-hematopoietic tumor.

Provided herein are methods and compositions for generating engineered cells, such as cells expressing a recombinant receptor, including methods involving stimulation and/or engineering of an input composition having a defined ratio of naive-like CD4+ T cells to naive-like CD8+ T cells. In particular, the methods can be used to engineer T cells with genetically engineered receptors, such as genetically engineered antigen receptors such as engineered (recombinant) TCRs and chimeric antigen receptors (CARs), or other recombinant chimeric receptors. Features of the methods include producing a more consistent and/or predictable T cell product and/or a product with lower toxicity compared with other methods.