The US Food and Drug Administration (FDA) has approved Kyverna Therapeutics’ Investigational New Drug (IND) application of KYV-101 chimeric antigen receptor (CAR) T-cell therapy for a Phase II trial to treat stiff-person syndrome (SPS) patients.

KYV-101 is an autologous, fully human anti-CD19 CAR T-cell product candidate designed for use in patients with B cell-driven autoimmune diseases.

This clearance will allow the initiation of the KYSA-8 Phase II trial for the treatment of SPS, a rare and debilitating neurological autoimmune disorder.

SPS is characterised by progressive muscle stiffness and spasms, severely impacting mobility and quality of life.

Currently, there is no cure for SPS, with available treatments only addressing symptom management.

Kyverna rare diseases business unit head Sham Dholakia said: “The IND clearance gives us confidence in our dedication to bringing a potential paradigm shift in the treatment of patients suffering from SPS and reaffirms a target dose of 100 million cells for KYV-101.”

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Originally designed by the National Institutes of Health (NIH), the CAR in KYV-101 has undergone a Phase I trial in oncology involving 20 patients.

Currently, Kyverna’s KYV-101 is undergoing evaluation in sponsored, open-label, Phase I/II and Phase II trials in the US and Germany.

These trials span across rheumatology and neurology, two major areas of autoimmune disease research.

The CAR in KYV-101 was used to treat 50 patients so far in both oncological and autoimmune conditions at more than 15 sites in the US and Europe.

The company also reports that KYV-101 is part of investigator-initiated trials for various indications in multiple regions.

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