Cabaletta Bio, Inc. is a biotechnology firm in the clinical development stage, specializing in the invention and advancement of sophisticated engineered T cell therapies. Its core mission is to treat autoimmune diseases where B cells are implicated in producing harmful autoantibodies. The company's unique chimeric autoantibody receptor (CAAR) T cell platform is engineered to precisely target and eradicate these specific disease-causing B cells. Leading its pipeline is DSG3-CAART, which is currently in Phase I clinical trials. This candidate is being assessed for efficacy in two distinct conditions: mucosal pemphigus vulgaris, an autoimmune blistering skin disorder, and Hemophilia A in patients exhibiting Factor VIII alloantibodies. Cabaletta's broader product candidate portfolio also includes MuSK-CAART, a preclinical asset aimed at a particular subset of myasthenia gravis patients; FVIII-CAART, in the discovery phase for another subgroup of Hemophilia A sufferers; and DSG3/1-CAART, also a discovery-stage program, designed for mucocutaneous pemphigus vulgaris. The company maintains strategic alliances, including a collaboration with the University of Pennsylvania and a research pact with The Regents of the University of California. Founded in 2017 as Tycho Therapeutics, Inc., it adopted the name Cabaletta Bio, Inc. in August 2018 and is based in Philadelphia, Pennsylvania.
Cabaletta Bio Presents New Rese-cel Phase 1/2 Clinical Data at ACR Convergence 2026 Featuring Immunomodulator-Free Durability and Favorable Benefit-Risk Profile Across Autoimmune Diseases
Cabaletta Bio presented new Phase 1/2 data on rese-cel at ACR Convergence 2026 showing durable, immunomodulator-free responses across autoimmune diseases.
All 6 dermatomyositis patients maintained moderate-to-major TIS responses through one year, all 5 biopsied lupus nephritis patients achieved DORIS remission, and 71% of systemic sclerosis patients hit rCRISS-50 at one year with 9% mean FVC improvement in lung-disease patients.
Across 71 patients, 94% had no or Grade 1 cytokine release syndrome and no IEC-HS was reported, reinforcing the benefit-risk profile.
The company reaffirmed plans for registrational DM/ASyS topline data in the second half of 2027 and a BLA submission in myositis in Q1 2028.