Kyverna Therapeutics today announced that KYV-101 was generally well tolerated with no report of immune effector cell-associated neurotoxicity syndrome (ICANS) after the standard 28-day post infusion observation period of the first U.S. patient enrolled in its Phase 1 clinical trial in subjects with relapsed or refractory lupus nephritis (LN).
28-day post-infusion data support KYV-101 safety profile KYV-101 is a novel, fully human CD19 CAR T-cell therapy designed for use in patients with B cell-driven autoimmune diseases The open-label, Phase 1 clinical trial in the U.S. is actively recruiting patients with LN at multiple sites, with additional patients being treated with KYV-101 for multiple indications in Europe EMERYVILLE, Calif., Sept. 13, 2023 /PRNewswire/ -- Kyverna Therapeutics (“Kyverna”), a clinical-stage cell therapy company with the mission of engineering a new class of therapies for serious autoimmune diseases, today announced that KYV-101 was generally well tolerated with no report of immune effector cell-associated neurotoxicity syndrome (ICANS) after the standard 28-day post infusion observation period of the first U.S. patient enrolled in its Phase 1 clinical trial in subjects with relapsed or refractory lupus nephritis (LN). The KYV-101 infusion occurred earlier in July at the University of Colorado Anschutz Medical Campus. KYV-101 is a novel, fully human anti-CD19 chimeric antigen receptor (CAR) T-cell therapy for use in B cell-driven autoimmune diseases such as LN and represents an innovative approach to fighting autoimmune diseases by harnessing the power of the body’s immune system. “There is a growing need for therapies that can drive greater and more rapid reduction of disease activity in patients with lupus nephritis. Cell-based therapies offer a potential new approach to very complex, and often challenging to treat, severe medical conditions,” said Amber Podoll, M.D., FASN, Associate Professor, University of Colorado Anschutz Medical Campus, and one of the principal investigators of the study. “We are proud of our collaboration with Dr. Podoll and her team in providing potentially life-changing therapeutic options to patients suffering from autoimmune diseases. We expect to present data from more patients in the coming months and at our symposium at the ACR Convergence Meeting this November in San Diego.” said Peter Maag, Ph.D., chief executive officer of Kyverna Therapeutics. “Our ability to consistently deliver on our promise of a seamless patient experience is a testament to our commitment to become best-in-class in the treatment of B-cell-driven autoimmune diseases.” 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. Additional patients are currently under treatment with KYV-101 in Europe for multiple indications. 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. About Lupus Nephritis (LN) About KYV-101 About Kyverna Therapeutics References:
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