Author Archives: Marisa Wexler, MS

First SLE patient dosed in CAR T-cell therapy Phase 1 trial

The first participant has been treated in a Phase 1 clinical trial testing the CAR T-cell therapy CC-97540 (BMS-986353) in people with severe systemic lupus erythematosus (SLE). “The opportunity to provide lupus patients with access to this treatment, all while ensuring they receive the highest level of care, is…

Hydroxychloroquine doesn’t seem to lower lupus preeclampsia risk

The antimalarial agent hydroxychloroquine doesn’t appear to lower the risk of preeclampsia during pregnancy in women with lupus, a study reports. The study, “Hydroxychloroquine in lupus pregnancy and risk of preeclampsia,” was published in Arthritis & Rheumatology. Preeclampsia is a pregnancy complication marked by high…

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,…

CAR T-cell therapy IMPT-514 gets FDA fast track designation for lupus

The U.S. Food and Drug Administration (FDA) has granted fast track designation to IMPT-514, a CAR T-cell therapy being developed by Immpact Bio for people with active, treatment-resistant lupus nephritis and systemic lupus erythematosus (SLE). Lupus nephritis is a serious complication of lupus characterized by kidney inflammation.

Greater use of Benlysta, Saphnelo seen in US, EU to treat lupus

In both the U.S. and Europe, clinicians want to limit treatment with glucocorticoids — steroid hormones whose long-term use for autoimmune diseases is tied to serious side effects — among people with moderate to severe lupus. To that end, healthcare professionals are increasingly prescribing biological therapies like Benlysta…