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August 5 , 2021 Cabaletta Bio® Cabaletta Bio Reports Second Quarter 2021 Financial Results and Provides Business Update - Company continues to make progress on the DesCAARTes ™ trial for DSG3 - CAART ; expects to report second and third cohort safety data in 3Q21 and 4Q21 , respectively , and data on target engagement 3 to 6 months after each completed cohort- - Investigational New Drug ( IND ) application submission to U.S. Food and Drug Administration ( FDA ) for MuSK - CAART expected in 2H21 and pre - IND meeting request submitted to FDA for PLA2R - CAART- PHILADELPHIA , Aug. 05 , 2021 ( GLOBE NEWSWIRE ) -- Cabaletta Bio , Inc. ( Nasdaq : CABA ) , a clinical - stage biotechnology company focused on the discovery and development of engineered T cell therapies for patients with B cell - mediated autoimmune diseases , today reported financial results for the second quarter ended June 30 , 2021 , and provided a business update . " During the quarter , we did not observe any clinically relevant adverse events in the first , low - dose patient cohort of the DesCAARTes ™ clinical trial for DSG3 - CAART , our lead clinical product candidate for the treatment of patients with mucosal - dominant pemphigus vulgaris . We remain well - positioned to achieve multiple near - term clinical milestones for this program , including our plan to report safety data from the higher dose second and third patient cohorts in the third and fourth quarters of 2021 , respectively , as well as target engagement data 3 to 6 months after each cohort is completed , ” said Steven Nichtberger , M.D. , Chief Executive Officer and Co - founder of Cabaletta . " Additionally , we remain on track to submit an IND to the FDA for MUSK - CAART , our lead preclinical product candidate , and we expect to conduct a pre - IND meeting with the FDA to discuss the development path for PLA2R - CAART in the second half of 2021. " Autoimmune Disease - Focused Pipeline Highlights and Anticipated Upcoming Milestones DSG3 - CAART : Desmoglein 3 chimeric autoantibody receptor T ( DSG3 - CAART ) cells as a potential treatment for patients with mucosal - dominant pemphigus vulgaris ( mPV ) . • In May 2021 , Cabaletta announced acute safety data from three patients in the first cohort in the DesCAARTes ™ trial . As of August 4 , 2021 , no dose limiting toxicities ( DLTs ) or clinically relevant adverse events , including cytokine release syndrome or neurotoxicity , were observed . These safety data were observed with an administered dose of 20 million DSG3 - CAART cells , without preconditioning and in the presence of circulating anti - DSG3 antibodies . DSG3 - CAART was detected at low levels via qPCR in all three patients during the 28 - day DLT monitoring window .