The US Food and Drug Administration (FDA) has given clearance for Kyverna Therapeutics’ investigational new drug (IND) application to begin a Phase II clinical trial of KYV-101 for myasthenia gravis.

The KYSA-6 trial will analyse KYV-101’s ability to treat adults with the autoimmune disease.

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 US National Institutes of Health (NIH) designed the CAR in KYV-101 to enhance tolerability and the product candidate is specifically intended for the treatment of B cell-driven autoimmune diseases.

Kyverna Therapeutics intends to evaluate KYV-101 for further indications and establish a pipeline of immunotherapies for autoimmune diseases.

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Kyverna Therapeutics CEO Peter Maag said: “We are grateful that the FDA’s decision to clear the IND for our Phase II KYSA-6 trial will allow Kyverna to offer this potentially paradigm-shifting investigational treatment to patients that may benefit from a deep B cell depletion and possibly durable reset of their immune system.”

KYV-101 is currently being analysed for active lupus nephritis in the Phase I KYSA-1 trial in the US and Phase I/II KYSA-3 trial in Germany.

Another Phase I/II KYSA-5 trial is evaluating the CART cell therapy’s efficacy in treating cutaneous systemic sclerosis in the US.

Otto-von-Guericke University Neurology department director Prof Aiden Haghikia said: “We have seen firsthand the transformative effects of KYV-101 in MG patients treated with the investigational therapy in our clinic.

“I welcome the FDA’s decision and look forward to more clinical data to further our knowledge about CAR T-cell therapy in patients with severe neurological autoimmune diseases.”

Earlier this year, Kyverna Therapeutics began enrolling subjects in a Phase I trial to evaluate KYV-101’s ability to treat lupus nephritis.

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

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