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Kyverna Therapeutics’ KYV-101 is a new, fully human anti-CD19 chimeric antigen receptor (CAR) T-cell therapy. Credit: Meletios Verras via Shutterstock.com.

Kyverna Therapeutics has enrolled the first participant in its Phase I clinical trial of KYV-101 to treat lupus nephritis (LN) in the US.

The dose escalation, open-label, multi-centre Phase I clinical trial has been designed for evaluating KYV-101’s safety in refractory LN patients.

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Approximately nine to 12 LN patients across the US are expected to be enrolled in the trial.

A new, fully human anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, KYV-101 has been designed for use in B cell-driven autoimmune diseases, such as LN.

It specifically targets CD19, which is a protein that is expressed on the B cell’s surface.

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B cells are involved in many types of malignancies, including autoimmune diseases.

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The company expects that its investigational CAR T-cell therapy may offer new hope for those patients who have exhausted tapping the conventional treatment options.

Kyverna Therapeutics CEO Peter Maag said: “We are immensely proud to have reached this significant milestone in our journey to transform the lives of patients battling life-altering ailments such as LN.

“Our KYV-101 cell therapy has the potential to revolutionise treatment for individuals suffering from autoimmune diseases, with patients currently being treated for multiple indications across the US and Europe.

“We look forward to advancing our clinical programmes so we can bring a new option to patients as quickly as possible.”

In November last year, the company received clearance for its investigational new drug (IND) application from the US Food and Drug Administration (FDA) to start the Phase I clinical trial of KYV-101 for LN treatment.

Cell & Gene Therapy coverage on Clinical Trials Arena is supported by Cytiva. 

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