Cabaletta Bio, Inc. ((CABA)) announced an update on their ongoing clinical study.
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RESET-SLE is a Phase 1/2 open-label study conducted by Cabaletta Bio, Inc. to evaluate the safety and efficacy of CABA-201 in patients with active Systemic Lupus Erythematosus (SLE). The study aims to assess the potential of CABA-201, a CD19-specific Chimeric Antigen Receptor T Cell therapy, to provide a new treatment option for SLE, a chronic autoimmune condition with limited effective treatments.
The intervention being tested is CABA-201, a biological treatment involving a single intravenous infusion following preconditioning with fludarabine and cyclophosphamide. This treatment is designed to target and potentially modulate the immune response in patients with SLE.
The study follows an interventional design with a single-group assignment across two parallel cohorts, focusing on treatment as the primary purpose. There is no masking involved, meaning all participants and researchers are aware of the treatment being administered.
The study began on October 23, 2023, with an estimated primary completion date in 2025. The most recent update was submitted on October 3, 2025. These dates are critical as they provide a timeline for when initial results might be expected, which can influence investor decisions.
This update from Cabaletta Bio could potentially impact their stock performance positively, as successful results may lead to a new treatment option for SLE, a significant market opportunity. Investors should also consider the competitive landscape, as advancements in autoimmune disease treatments are highly sought after.
The study is currently ongoing, with further details available on the ClinicalTrials portal.