DFT383

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DFT383
Clinical data
Drug classgene therapy

DFT383 is an investigational gene therapy under development by Novartis for the treatment of cystinosis, a rare autosomal recessive lysosomal storage disorder caused by mutations in the CTNS gene, leading to cystine accumulation in cells.[1]

The therapy delivers a functional copy of the CTNS gene via autologous hematopoietic stem cell (HSC) transplantation to address the disease’s root cause, targeting patients both pre- and post-kidney transplant.[2]

DFT383 involves extracting a patient’s hematopoietic stem cells, genetically modifying them ex vivo with a lentiviral vector to insert a functional CTNS gene, and reinfusing them after myeloablation.[3]

The modified cells are intended to produce functional cystinosin, a lysosomal cystine-proton symporter, reducing cystine accumulation throughout the body, including in the kidneys, eyes, and other organs.[4]

In preclinical studies using Ctns−/− mice, treatment with lentiviral-based CTNS gene therapy resulted in significant reductions in tissue cystine levels and preservation of kidney, eye, and thyroid function.[5]

Development history

References

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