News

Off-the-shelf CAR cell therapy to enter SLE trial next year

The U.S. Food and Drug Administration (FDA) has cleared Century Therapeutics to start a Phase 1 clinical trial that will test its off-the-shelf cell therapy CNTY-101 in people with systemic lupus erythematosus (SLE). The Phase 1 study will enroll people with moderate to severe SLE who’ve failed to respond…

Phase 1/2 Trial of GC012F in hard-to-treat SLE expected by 2024

The U.S. Food and Drug Administration (FDA) has given Gracell Biotechnologies the green light to start a Phase 1/2 clinical trial to test its experimental cell therapy GC012F in people with difficult-to-treat systemic lupus erythematosus (SLE). The study’s Phase 1 portion should start in 2024 to assess the safety,…

Specific autoantibodies can raise cardiovascular disease risk with SLE

Certain self-reactive antibodies, called antiphospholipid antibodies (aPLs), significantly increase the risk of a heart attack, stroke, or other cardiovascular event in people with systemic lupus erythematosus (SLE), a study shows. Among aPLS, “we identified that [anticardiolipin antibodies] and lupus anticoagulant positivity are independently associated with [cardiovascular disease], after adjusting…

Otsuka seeks approval in Japan of Lupkynis for lupus nephritis

Otsuka Pharmaceutical is seeking approval in Japan to manufacture and market Lupkynis (voclosporin) for the treatment of lupus nephritis, a kidney complication of systemic lupus erythematosus (SLE). The new drug application filed by Otsuka will be reviewed and decided upon by the Japanese Ministry of Health, Labour,…

CAR T-cell therapy shown to drive long-term remission in SLE patients

A CAR T-cell therapy targeting B-cells, a type of immune cells, was found to clear disease-causing autoantibodies from the bloodstream of eight people with systemic lupus erythematosus (SLE) — without compromising the patients’ ability to respond to vaccines — new trial data show. The experimental therapy also drove the…

Kyverna, Charité partner to study effects of B-cell-targeting therapies

Kyverna Therapeutics has signed a research funding deal with Charité – Universitätsmedizin Berlin, in Germany, to study how therapies targeting immune B-cells may improve clinical outcomes of people with whole-body, or systemic, autoimmune diseases such as lupus. The deal also covers studies on CAR T-cell therapies, including Kyverna’s experimental…

2 young scientists receive Lupus Foundation grants for research

This year’s winners of the Lupus Foundation of America‘s Gary S. Gilkeson Career Development Award — designed to support early career scientists working on lupus research — will focus their work on areas key to patients with the autoimmune disease: pregnancy and personalized medicine. Both winners are from…