First patient enrolled in Phase 1 trial of KYV-101 CAR-T cell therapy

Investigational treatment for refractory lupus nephritis recruiting in US

Patricia Inacio, PhD avatar

by Patricia Inacio, PhD |

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The first patient has been enrolled in a Phase 1 clinical trial testing KYV-101, Kyverna Therapeutics’ candidate cell therapy for refractory lupus nephritis, a serious lupus complication characterized by kidney damage and inflammation.

The open-label trial, which follows FDA’s green light in November, is actively recruiting nine to 12 patients across several clinical sites in the U.S., where it will test the safety of escalating doses of KYV-101. The company also is looking to launch a similar Phase 1/2 trial in Germany.

“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 [lupus nephritis],” Peter Maag, PhD, CEO of Kyverna Therapeutics, said in a company press release.

Lupus is an autoimmune disease, meaning it is caused by the immune system wrongly attacking the body’s own tissues. In nearly half of adults, the disease progresses into lupus nephritis, and around 60% of these patients are refractory, or fail to respond, to current therapies.

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CAR T-cell therapy reduces severity of autoimmune attacks

The autoimmune attack in lupus is driven mainly by B-cells, a type of immune cell responsible for producing antibodies.

KYV-101 is a CAR T-cell therapy designed to reduce the severity of the autoimmune attacks driven by these cells. As a first step, a patient’s own T-cells — a type of immune cell that can attack and destroy other cells — are collected and engineered in the lab to recognize a specific protein. In this case, T-cells are designed to recognize the CD19 protein found on the surface of B-cells.

Engineered T-cells are then expanded and infused back to the patient, where they are expected to attack and destroy B-cells.

According to Kyverna, KYV-101 may be an alternative for patients who fail to respond to conventional treatments. In June, KYV-101 was given fast track designation by the U.S. Food and Drug Administration (FDA) for the treatment of refractory lupus nephritis.

Preclinical data showed that KYV-101 generated from patients with systemic lupus erythematosus or lupus nephritis successfully targeted B-cells for destruction.

Moreover, data from a previous Phase 1/2 study (NCT02659943) showed the candidate therapy had anti-cancer and anti-inflammatory activity among 20 people with B-cell cancers. Supported by these findings, the company is conducting clinical trials testing KYV-101 in other B-cell driven autoimmune disorders across the U.S. and Europe.

“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,” said Maag. “We look forward to advancing our clinical programs so we can bring a new option to patients as quickly as possible.”