Upcoming US clinical trial will test CLN-978 as Sjögren’s treatment
Dosing study to enroll patients with active, moderate to severe disease
Cullinan Therapeutics is planning the launch of a clinical trial in the U.S. to test its treatment candidate CLN-978 in people with Sjögren’s disease.
The study will be open to Sjögren’s patients whose disease is active and moderate to severe, and who are positive for anti-SSA/Ro antibodies and/or rheumatoid factor. These are antibodies made by the immune system that are thought to be involved in Sjögren’s disease.
The trial is expected to start before the end of June, according to Cullinan.
“We look forward to opening this new trial to patients with Sjögren’s disease in the U.S.,” Jeffrey Jones, MD, chief medical officer for Cullinan, said in a company press release.
Sjögren’s treatment given as under-the-skin injection
Sjögren’s is an autoimmune disease in which the immune system attacks the body’s own healthy tissues. Antibodies, which are proteins made by immune cells called B-cells, are thought to play a key role in this autoimmune attack.
A novel treatment candidate, according to Cullinan, CLN-978 aims to ease disease severity in Sjögren’s by depleting B-cells. The therapy specifically works by targeting CD19, a protein found in B-cells. At the same time, CLN-978 also binds to a protein complex in T-cells, another type of immune cells able to kill other cells. By simultaneously binding to CD19 and T-cells, CLN-978 essentially aims to trigger T-cells to destroy B-cells.
The therapy is administered via a subcutaneous, or under-the-skin, injection.
“CLN-978, our investigational, novel bispecific T-cell engager, targets CD19 and offers a highly differentiated approach to deplete B cells deeply with an off-the-shelf product and convenient subcutaneous administration,” Jones said.
In addition to Sjögren’s disease, Cullinan is developing CLN-978 for systemic lupus erythematosus (SLE) and rheumatoid arthritis. Both diseases are thought to be driven by the aberrant activity of B-cells, much like Sjögren’s.
“We are pleased to rapidly progress our global clinical development program for CLN-978, now open for patients living with systemic lupus erythematosus, rheumatoid arthritis, and soon Sjögren’s disease,” Jones said.
Teja Kapoor, MD, assistant professor of medicine at the Columbia University College of Physicians and Surgeons, noted that SLE and Sjögren’s “share a complex and often debilitating overlap, leaving many patients struggling with chronic pain, fatigue, and organ involvement.” Kapoor said she is “encouraged by new research approaches such as CLN-978 that aim to modify the disease and offer sustainable relief to patients.”
According to Kapoor: “Despite advancements, there remains a significant unmet need for targeted therapies that address the root causes of these autoimmune conditions.”
Cullinan noted in the release that testing in SLE and rheumatoid arthritis already is underway.
We are encouraged to see new research approaches aimed at providing patients with better treatment options to improve their quality of life.
The main goal of the upcoming Sjögren’s trial will be to evaluate the safety and tolerability of CLN-978 in patients. The study, which will use a dose escalation scheme similar to the one used in the ongoing SLE trial, will also explore the therapy’s pharmacological properties and its effects on disease activity.
Janet Church, president and CEO of the Sjögren’s Foundation, noted that “there are an estimated 4 million Americans” with Sjögren’s.
“Yet it is underdiagnosed and frequently misunderstood,” Church said. “There are currently no treatments that comprehensively address the complexities of Sjögren’s or slow the progression of the disease. We are encouraged to see new research approaches aimed at providing patients with better treatment options to improve their quality of life.”
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