KYV-101 is also being assessed in investigator-initiated trials for multiple indications. Credit: Alex_Traksel/Shutterstock.com.

Kyverna Therapeutics has published a report detailing the first-in-disease use of KYV-101 in patients with progressive multiple sclerosis (MS) under a named patient programme in Germany.

This follows the failure of conventional therapies in two patients.

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KYV-101 is a fully human CD19 chimeric antigen receptor (CAR) T-cell therapy that is designed to act on the CD19 protein. This protein is expressed on the B cell surface and is associated with myasthenia gravis and several other autoimmune diseases.

The treatment with KYV-101 demonstrated an acceptable safety profile, with no signs of early neurotoxicity observed, suggesting the potential for larger clinical studies in MS subjects.

Designed by the National Institutes of Health (NIH), the CAR in KYV-101 aims to enhance tolerability and has been tested in a 20-patient Phase I clinical trial in oncology, with results published in Nature Medicine.

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Currently, Kyverna is assessing KYV-101 in open-label, Phase I/II trials for lupus nephritis, where over half of the patients do not achieve a complete response to existing treatments.

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The FDA has also cleared an investigational new drug (IND) application for Phase II trials of KYV-101 in multiple sclerosis and myasthenia gravis, and a Phase I/II trial for systemic sclerosis.

Kyverna CEO Peter Maag said: “We are committed to transforming the standard of treatment for patients living with multiple sclerosis.

“The pioneering work done with KYV-101 by medical teams in Hamburg and in our trials in the US helps build the data backbone needed to further advance our knowledge and hopefully accelerate development of CAR T-cell therapies in autoimmune diseases.”

In addition to sponsored trials, KYV-101 is being assessed in investigator-initiated trials for multiple indications across various geographies.