Phase 1 open-label clinical trial in the U.S. is actively recruiting patients with LN at multiple sites
Patients in treatment with KYV-101 for multiple indications across the U.S. and Europe "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 revolutionize treatment for individuals suffering from autoimmune diseases, with patients currently being treated for multiple indications across the U.S. and Europe. We look forward to advancing our clinical programs so we can bring a new option to patients as quickly as possible," said Peter Maag, Ph.D., chief executive officer of Kyverna Therapeutics. The open label, dose escalation, multi-center clinical trial is designed to assess the safety of KYV-101 in patients with refractory LN. The study is targeted to enroll approximately 9-to-12 patients with LN across the U.S. CAR T-cell therapy involves modifying a patient's immune T cells to recognize and remove B cells in the patient's body. Kyverna's anti-CD19 CAR T-cell therapy, KYV-101, specifically targets CD19, a protein expressed on the surface of B cells, which are involved in various types of malignancies, including autoimmune diseases. This experimental treatment may offer new hope to patients who have exhausted conventional treatment options. As more patients commence their journey with KYV-101, Kyverna continues to explore additional indications for this therapy, as well as develop a robust pipeline of promising immunotherapies aimed at addressing unmet medical needs. Lupus nephritis (LN) is a serious complication of systemic lupus erythematosus (SLE), more commonly known as lupus. Approximately 40 percent of adults diagnosed with lupus eventually develop LN and 60 percent of LN patients will fail standard of care and approved treatments1. Aside from modest efficacy, current treatments expose these young adults to the well-demonstrated detrimental consequences of chronic treatment with corticosteroids and other powerful immunosuppressants. Up to 10 percent of patients with LN and 40 percent with diffuse LN (class IV) will ultimately develop kidney failure, requiring dialysis or a kidney transplant to stay alive2. 1 E. Carter et al., Nature Reviews Rheumatology, 12, Oct. 2016, 605-620.
2 Adv Chronic Kidney Dis. 2019;26(5):313.
3 Brudno et al., Nature Medicine 2020; 26:270-280.