Cabaletta Bio, a Philadelphia-based late-stage clinical biotechnology company developing cell therapies for autoimmune diseases, shared new data on its investigational CAR T cell therapy at the American College of Rheumatology (ACR) Convergence 2026 annual meeting in Orlando, Florida, the company announced on November 8, 2026. The Phase 1/2 results for resecabtagene autoleucel (rese-cel) cover patients with dermatomyositis, lupus nephritis, and systemic sclerosis, plus safety data from 71 patients.
“In three different autoimmune diseases where patients are at risk of severe disability, end-organ damage, and increased risk of death despite current therapies, a single weight-based dose of rese-cel delivered immunomodulator-free clinical improvements that were durable through at least one year with a favorable benefit-risk profile,” said David J. Chang, M.D., Chief Medical Officer of Cabaletta.
Inside the Data
Rese-cel is a chimeric antigen receptor (CAR) T cell therapy that targets CD19, a protein found on B cells. Patients in the open-label, single-arm studies received a single, weight-based infusion after preconditioning. They stopped all immunomodulators, the drugs typically used to suppress the immune system, before treatment. The data cutoff was September 4, 2026.
Dermatomyositis: All six patients maintained a moderate-to-major response on the Total Improvement Score (TIS) through one year without immunomodulators. Five of the six reached that level by Week 16, the timepoint that matches the primary endpoint of Cabaletta’s ongoing registrational study. Most were also off steroids at Week 52.
Lupus nephritis: Five patients chose to have a repeat kidney biopsy after treatment. All five met the Definition of Remission in SLE (DORIS) criteria without immunomodulators and on no or low-dose steroids. All five biopsies also showed histologic response or remission, meaning improvement visible in the kidney tissue itself.
Systemic sclerosis: At one year, five of seven patients (71%) achieved rCRISS-50, a composite measure of improvement, and six of seven reached rCRISS-25. The five patients with interstitial lung disease saw an average 9% improvement in forced vital capacity (FVC), a measure of lung function.
Safety Across 71 Patients
Across 71 patients with myositis, systemic sclerosis, lupus, and myasthenia gravis, 94% had no cytokine release syndrome (CRS) or only Grade 1 CRS, an immune reaction common with CAR T therapies. Four patients (6%) had Grade 2 CRS. Of the 71 patients, 68 (96%) had no immune effector cell-associated neurotoxicity syndrome (ICANS). No cases of a related hyperinflammatory syndrome (IEC-HS) were reported.
Cabaletta attributes the safety profile to rese-cel’s design, including a fully human CD19 binder, weight-based dosing, and a standard nine-day manufacturing process.
What’s Next
Cabaletta expects topline results from its registrational dermatomyositis and antisynthetase syndrome cohort in the second half of 2027. It plans to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for rese-cel in myositis in the first quarter of 2028. The company is also enrolling a registrational cohort in systemic sclerosis focused on interstitial lung disease.
About Cabaletta Bio
Cabaletta is advancing rese-cel through its REstoring SElf-Tolerance (RESET™) clinical development program, which spans rheumatology, neurology, and dermatology. Its trials are designed to evolve directly into registrational studies. The company’s headquarters and labs are in Philadelphia.
Forward-Looking Statements
This press release contains “forward-looking statements” of Cabaletta Bio within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including without limitation, express or implied statements regarding: Cabaletta’s business plans and objectives as a whole; Cabaletta’s ability to realize its vision of launching curative targeted cell therapies designed specifically for patients with autoimmune diseases; Cabaletta’s ability to successfully complete research and further development and commercialization of its drug candidates in current or future indications, including the timing and results of Cabaletta’s clinical trials and its ability to conduct and complete clinical trials; expectation that clinical results will support rese-cel’s safety and activity profile; Cabaletta’s expectations regarding the timing of topline results from the registrational DM/ASyS cohort in the second half of 2027 and its plans to submit a BLA for rese-cel in myositis, inclusive of adult and juvenile DM data, in 1Q28; Cabaletta’s expectations regarding the inclusion of multi-year Phase 1/2 myositis durability data in its planned BLA submission based on its recent Type B regulatory interaction with the FDA; Cabaletta’s expectations regarding the potential eligibility for a Priority Review Voucher based on a potential pediatric indication for juvenile DM; Cabaletta’s plans and expectations regarding the registrational RESET-SSc cohort in systemic sclerosis-associated interstitial lung disease, including enrollment, trial design, and timing of data read-outs; the potential applicability of Phase 1/2 clinical data to registrational cohorts; Cabaletta’s interpretation of clinical data, including lupus nephritis kidney biopsy findings and the characterization of persistent proteinuria as reflective of structural damage predating treatment; statements regarding the mechanistic basis of activity and favorable benefit-risk profile of rese-cel, including conclusions drawn from pharmacokinetic, pharmacodynamic and cytokine data described in a publication; the significance of the clinical data read-out at upcoming scientific meetings and timing thereof; and Cabaletta’s expectations around the potential success and therapeutic benefits of rese-cel, including the durability of clinical responses, its benefit-risk profile and its potential as a one-time infusion.
Any forward-looking statements in this press release are based on management’s current expectations and beliefs of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: risks related to regulatory filings, potential clearance and potential approval; the risk that preclinical or clinical data, including signs of biologic activity or clinical response, may not be predictive of long-term results or translate across programs; the risk that interim data may change as more patient data become available; Cabaletta’s ability to demonstrate sufficient evidence of safety, efficacy and tolerability in its preclinical studies and clinical trials of rese-cel; the risk that the results observed with the similarly-designed construct employed in academic publications, including due to the dosing regimen, are not indicative of the results Cabaletta seeks to achieve with rese-cel; risks that modifications to trial design or approach may not have the intended benefits and that the trial design may need to be further modified; risks related to clinical trial site activation, delays in enrollment generally or enrollment rates that are lower than expected; delays related to assessment of clinical trial results; risks related to unexpected safety or efficacy data observed during clinical studies; risks related to volatile market and economic conditions and public health crises; Cabaletta’s ability to retain and recognize the intended incentives conferred by Orphan Drug Designation, Fast Track Designation, Regenerative Medicine Advanced Therapy Designation or other designations for its product candidates, as applicable; risks related to Cabaletta’s ability to protect and maintain its intellectual property position; risks related to fostering and maintaining successful relationships with Cabaletta’s collaboration and manufacturing partners; uncertainties related to the initiation and conduct of studies and other development requirements for its product candidates; the risk that any one or more of Cabaletta’s product candidates will not be successfully developed and/or commercialized; and the risk that the initial or interim results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Cabaletta’s actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in Cabaletta’s most recent annual report on Form 10-K as well as discussions of potential risks, uncertainties, and other important factors in Cabaletta’s other subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Cabaletta undertakes no duty to update this information unless required by law.
Source: Cabaletta Bio, https://www.cabalettabio.com/news-media/press-releases/detail/156/cabaletta-bio-presents-new-rese-cel-phase-12-clinical-data on November 8, 2026. Republished with credit to the original author. Read the original article.
