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YTB323

A chimeric antigen receptor (CAR) is a cellular receptor engineered to connect an extracellular targeting function with intracellular domains that activate the cytotoxic potential of T cells. CAR (Chimeric Antigen Receptor) T cells are T cells that have been engineered with additional receptors to identify specific proteins, called antigens, present on the surface of other cells. The Chimeric Antigen Receptor T cells for Autoimmunity (CARTA) approach is designed to transiently, but fully, eliminate B cells, thus potentially enabling an “immune system reset.” YTB323 is a novel, rapidly manufactured, autologous CAR-T cell therapy.

Wavy Abstract Background

Enroll in this clinical study

Novartis Pharmaceuticals

+1-888-669-6682

novartis.email@novartis.com

How is YTB323 being studied in Lupus nephritis?

The safety, efficacy and cellular kinetics of YTB323 in participants with severe, refractory Systemic Lupus Erythematosus is being studied in this open-label, Multi-center, Phase 1/2 Study. The primary is the number of participants with adverse effects and severe adverse effects. The secondary outcomes include assessment of cellular kinetics by measurement of CAR transgene levels by quantitative polymerase chain reaction (qPCR) in blood.

Eligibility Criteria

  1. Aged 18-65 years

  2. Active (severe) disease as defined by SLEDAI-2K ≥ and at least one of the following significant SLE related organ involvements:

    1. Renal

    2. At least moderate or severe peri/myocarditis

    3. At least moderate or severe pleuritis or other lung involvement

    4. Vasculitis

  3. Failure to respond to two or more standard immunosuppressive therapies (including one of mycophenolate or cyclophosphamide), unless contraindicated or having experienced documented adverse events or intolerance related to such immunosuppressive drugs not allowing their further use, in combination with glucocorticoids and failure to respond to at least one biological agent.

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