The US FDA has cleared the third IND application to initiate a P-I/II study of KYV-101, an autologous fully human anti-CD19 CAR T cell therapy for the treatment of diffuse cutaneous systemic sclerosis (scleroderma)
KYV-101 is currently being studied in an ongoing P-I trial (KYSA-1) in the US and a P-I/II trial (KYSA-3) in Germany for adults with active lupus nephritis. The therapy is designed to modify a patient’s T cells to target CD19
In a P-I/II trial in oncology, KYV-101 demonstrated anti-lymphoma activity along with a significant reduction of cytokines. Kyverna gained exclusive, global licenses from the NIH to use this CD19 construct in autologous as well as allogeneic CAR T-cell therapies
Ref: PRNewswire | Image: Kyverna Therapeutics
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