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AlloNK®(AB-101) in Combination With B-Cell Depleting Antibodies in Autoimmune Disease

What is cell therapy? How does it work in autoimmune disease?

  • Cell therapies utilize a living cell (rather than a chemical or biologic) as the therapy. Currently, most cell therapies are derived from a patient’s own cells (autologous) and are genetically modified to express a CAR (Chimeric Antigen Receptor) to target antigens present on the surface of diseased cells.

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  • Autologous CD19-targeted CAR T-cell therapy was tested in various autoimmune diseases, published by Muller et al in 2024 in the New England Journal of Medicine, showing:

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  • Deep depletion of patients’ B-cells for 3-6 months, leading to resolution of proteinuria and SLEDAI-2K scores of 0 in SLE patients, all of whom remained in remission at time of publication without immunosuppressive drugs or glucocorticoids.

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  • The therapy was also tested in in a small number of patients with systemic sclerosis and myositis, and a therapeutic effect was observed in all patients.

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  • However, patients were apheresed to create the individualized treatment, were hospitalized for ~10 days following treatment, and the majority experienced Cytokine Release Syndrome.

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What is AlloNK®(AB-101)?

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  • AlloNK is a non-genetically modified NK cell and is available off-the-shelf (as opposed to an autologous T-cell manufactured specifically for each patient) and is given by IV infusion, similar to biologics such as rituximab or belimumab.

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  • Unlike autologous CAR-T, which are genetically modified with a CAR construct for targeting, AlloNK is combined with an approved B-cell targeting antibody to deplete pathogenic B-cells.

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  • Clinical safety and activity data from a multi-center trial of AlloNK + rituximab in B-cell Non-Hodgkin Lymphoma demonstrates:

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  • Deep B-cell depletion.

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  • Feasibility of outpatient administration, with majority of patients not hospitalized at any time.

What indications is AlloNK being tested in?

  • Currently enrolling: SLE, with or without nephritis (NCT06265220)

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  • Exploring additional clinical trials in autoimmune indications such as rheumatoid arthritis, pemphigus vulgaris, ANCA-vasculitis, myositis, and systemic sclerosis

Could your site be a fit for our clinical trial?

  • AlloNK is a cryopreserved cell therapy, provided in an infusion-ready media, thawed at bedside, and administered with a 5-10 min IV push.

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  • AlloNK is given in combination with an IV infused monoclonal antibody, such as rituximab or obinutuzumab, and lymphodepleting therapy consisting of IV infused cyclophosphamide and fludarabine.

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