The US Food and Drug Administration (FDA) has granted clearance to Kyverna Therapeutics’ investigational new drug (IND) application enabling initiation of the Phase I/II KYSA-5 trial of KYV-101 to treat diffuse cutaneous systemic sclerosis (scleroderma).
The multicentre, open-label study will evaluate the autologous fully human anti-cd19 chimeric antigen receptor (CAR) T cell therapy KYV-101 in adult scleroderma patients.
Kyverna Therapeutics CEO Peter Maag said: “We are keen to initiate our KYSA-5 trial in this new patient population and generate data to support our KYV-101 design goals.
“With the deep B cell depletion from KYV-101 treatment, patients with scleroderma may have a full reset of their immune system to stop the vicious cycle of their overactive immune system.”
KYV-101 is also being investigated in Kyverna’s ongoing Phase I KYSA-1 trial in the US and the Phase I/II KYSA-3 study in Germany in adult subjects with active lupus nephritis.
In a 20-patient Phase I/II trial in oncology, KYV-101 demonstrated anti-lymphoma activity along with a significant reduction of cytokines.
At one month, the fully human anti-CD19 CAR also translated into reduced immunogenicity that impacted cell persistence favourably.
Kyverna gained exclusive, global licenses from the National Institutes of Health to use this CD19 construct in autologous as well as allogeneic CAR T-cell therapies.