Abstract: Provided herein are a method of treating type 1 diabetes (T1D). In some embodiments, such method can include administering to a subject in need thereof a 12-day course of teplizumab at a total dose of more than about 9000 ?g/m2.

Abstract: Provided herein, in one aspect, is a method of preventing or delaying the onset of clinical type 1 diabetes (TID), comprising: providing a non-diabetic subject who is at risk for TID; determining that the non-diabetic subject (1) is substantially free of antibodies against zinc transporter 8 (ZnT8), (2) is HLA-DR4+, and/or (3) is not HLA-DR3+; and administering a prophylactically effective amount of an anti-CD3 antibody to the non-diabetic subject.

Abstract: Provided herein are methods and compositions for treating type 1 diabetes. Also provided herein are methods and compositions for preventing or delaying the onset of type 1 diabetes. In some embodiments, such method can include administering to a subject in need thereof a 12-day to 14-day course of teplizumab at a total dose of about 9000 ?g/m2 to about 14000 ?g/m2 and administering an effective amount of a DYRK1A inhibitor.

Abstract: Type 1 diabetes (T 1 D) is caused by the autoimmune destruction of insulin producing beta cells in the islets of Langerhans leading to dependence on exogeneous insulin injections for survival. A need exists for a treatment that would prevent or delay the onset of clinical T1 D in high-risk individuals. One promising therapy is the anti-CD3 monoclonal antibody teplizumab, as several studies have shown that short-term treatment reduces loss of beta cell function durably, with an observable effect seen as long as 7 years after diagnosis and treatment. Furthermore, improved methods for prognosing such prevention or delay are also needed. Provided herein, in one aspect, is a method of prognosing responsiveness of an anti-CD3 antibody in preventing or delaying the onset of T1 D.

Abstract: Provided herein, in one aspect, is a method of preventing or delaying the onset of clinical type 1 diabetes (T1D), comprising: providing a non-diabetic subject who is at risk for T1D; administering a prophylactically effective amount of an anti-CD3 antibody to the non-diabetic subject; and determining, prior to or after the administering step, that the non-diabetic subject has more than about 5% to more than about 10% TIGIT+KLRG1+CD8+ T-cells in all CD3+ T-cells, which is indicative of successful prevention or delay of the onset of clinical T1D.

Abstract: Provided herein, in one aspect, is a method of preventing or delaying the onset of clinical type 1 diabetes (T1D), comprising: administering a prophylactically effective amount of an anti-CD3 antibody to a non-diabetic subject who is at risk of T1D, wherein the prophylactically effective amount has a cumulative dose of about 10,500 ?g/m2 to about 14,000 ?g/m2.

Abstract: Provided herein, in one aspect, is a method of preventing or delaying the onset of clinical type 1 diabetes (T1D), comprising: providing a non-diabetic subject who is at risk for T1D; determining that the non-diabetic subject (1) is substantially free of antibodies against zinc transporter 8 (ZnT8), (2) is HLA-DR4+, and/or (3) is not HLA-DR3+; and administering a prophylactically effective amount of an anti-CD3 antibody to the non-diabetic subject.

Abstract: Provided herein are a method of treating type 1 diabetes (T1D). In some embodiments, such method can include administering to a subject in need thereof a 12-day course of teplizumab at a total dose of more than about 9000 ?g/m2.

Abstract: Provided herein are a method of treating type 1 diabetes (T1D) post SARS-CoV-2 infection. In some embodiments, such method can include administering to a subject in need thereof a 12-day course of teplizumab at a total dose of more than about 9000 ?g/m2.

Abstract: Provided herein, in one aspect, is a method of preventing or delaying the onset of clinical type 1 diabetes (T1D), comprising: providing a non-diabetic subject who is at risk for T1D; determining that the non-diabetic subject (1) is substantially free of antibodies against zinc transporter 8 (ZnT8), (2) is HLA-DR4+, and/or (3) is not HLA-DR3+; and administering a prophylactically effective amount of an anti-CD3 antibody to the non-diabetic subject.