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

The results include one-year responses without immunomodulators, while registrational development continues in myositis and systemic sclerosis.

Rhea-AI Summary

Cabaletta Bio (CABA) reported new Phase 1/2 rese-cel data showing sustained improvements across three autoimmune diseases at ACR Convergence 2026.

The open-label, single-arm studies evaluated one infusion after preconditioning, with a September 4, 2026 cutoff. All six dermatomyositis patients maintained moderate-to-major Total Improvement Score responses without immunomodulators through one year. All five lupus nephritis patients with repeat biopsies achieved remission without immunomodulators and biopsy-based response or remission. In systemic sclerosis, 71% (5/7) achieved the rCRISS-50 disease-improvement threshold at one year. Among 71 patients, 94% had no or mild cytokine release syndrome, an inflammatory reaction; 6% had Grade 2 cases.

Cabaletta expects registrational adult dermatomyositis/antisynthetase syndrome results in second-half 2027 and a myositis biologics application in first-quarter 2028.

16 points · 0 major

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Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate point100% (6/6) of dermatomyositis patients maintained moderate-to-major Total Improvement Score responses without immunomodulators through one year.
• Moderate point100% (5/5) of biopsied lupus nephritis patients achieved remission without immunomodulators, on no or low-dose steroids.
• Moderate point71% (5/7) of systemic sclerosis patients achieved the rCRISS-50 disease-improvement threshold without immunomodulators at one year.
• Minor point83% (5/6) of dermatomyositis patients reached that response level by Week 16, the ongoing registrational cohort’s primary-endpoint timepoint.
• Minor pointMost dermatomyositis patients were also steroid-free at Week 52.

11 minor points

• Minor pointDermatomyositis improvements included muscle strength, skin manifestations, patient-reported physical function and fatigue.
• Minor point100% (5/5) of biopsied lupus nephritis patients demonstrated tissue-based response or remission.
• Minor point86% (6/7) of systemic sclerosis patients achieved the rCRISS-25 disease-improvement threshold at one year.
• Minor point9% improvement in mean percent-predicted forced vital capacity occurred at one year in five patients with interstitial lung disease.
• Minor pointSystemic sclerosis skin scores also improved at one year.
• Minor point94% (67/71) of patients experienced no or Grade 1 cytokine release syndrome, an inflammatory reaction.
• Minor point96% (68/71) of patients experienced no immune effector cell-associated neurotoxicity syndrome, a neurological complication.
• Minor pointNo cases of immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome, an inflammatory complication, were reported.
• Minor point. Forward-looking: it has not happened yet and may not happen.Second-half 2027 registrational adult dermatomyositis/antisynthetase syndrome topline results are anticipated by Cabaletta.
• Minor point. Forward-looking: it has not happened yet and may not happen.First-quarter 2028 myositis biologics application is anticipated, including adult dermatomyositis and all available juvenile dermatomyositis Phase 1/2 data.
• Minor pointRegistrational systemic sclerosis enrollment is underway with a focus on interstitial lung disease.

Negative

• Minor pointOpen-label, single-arm studies underpin the reported Phase 1/2 results.
• Minor pointGrade 2 cytokine release syndrome occurred in 6% (4/71) of patients.
• Minor pointLupus nephritis biopsy findings cover five patients who underwent optional repeat biopsies.

News Explained

Five patients with lung involvement showed a nine percent one-year lung-function improvement as Cabaletta enrolls its lung-focused registrational systemic-sclerosis cohort.

Cabaletta Bio announced additional Phase 1/2 rese-cel data for ACR Convergence 2026 and reports that its registrational systemic-sclerosis cohort focused on interstitial lung disease is enrolling.

Among five systemic-sclerosis patients with interstitial lung disease, mean percent-predicted FVC improved 9% at one year.

Key Figures

Dermatomyositis TIS response: 100% (6 of 6 patients) Lupus nephritis DORIS remission: 100% (5 of 5 patients) Histologic response or remission: 100% (5 of 5 patients) +4 more

Dermatomyositis TIS response

100% (6 of 6 patients)

Immunomodulator-free moderate-to-major responses through one year

Lupus nephritis DORIS remission

100% (5 of 5 patients)

Repeat-biopsy patients; remission off immunomodulators

Histologic response or remission

100% (5 of 5 patients)

Lupus nephritis patients who underwent repeat kidney biopsy

Systemic sclerosis rCRISS-50

71% (5 of 7 patients)

At one year

Mean percent-predicted FVC improvement

9%

At one year among five patients with interstitial lung disease

No or Grade 1 CRS

94% (67 of 71 patients)

Across the reported 71-patient clinical experience

No ICANS

96% (68 of 71 patients)

Across the reported 71-patient clinical experience

Previous Clinical trial Reports

2 past events · Latest: Oct 27

Same Type 2 events

1. Oct 27

   clinical data

   24h Move

   +13.0%

   All four registrational-criteria DM/ASyS patients achieved moderate/major TIS at week 16.

2. Feb 18

   clinical data

   24h Move

   -14.0%

   Reported three SLE DORIS remissions and the first lupus nephritis complete renal response.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

total improvement score (tis), forced vital capacity (fvc), cytokine release syndrome (crs), immune effector cell-associated neurotoxicity syndrome (icans), +1 more

5 terms

total improvement score (tis) medical

"moderate-to-major Total Improvement Score (TIS) response through one year"

Total Improvement Score (TIS) is a single numeric summary that combines several individual clinical measures into one percentage or point value to show how much patients improved in a trial. For investors, TIS turns complex medical results into an easy-to-compare “overall grade” that can influence regulators, prescribing labels and market confidence—so a higher TIS often supports a stronger commercial and regulatory outlook.

forced vital capacity (fvc) medical

"mean percent-predicted forced vital capacity (FVC) was observed at one year"

Forced vital capacity (FVC) is the total amount of air a person can forcefully exhale after taking the deepest breath possible, measured during a simple breathing test. Investors care because changes in FVC are a common, straightforward measure used in clinical trials and regulatory evaluations for respiratory drugs and devices, acting like a yardstick that shows whether a treatment is improving lung capacity or slowing disease progression.

cytokine release syndrome (crs) medical

"patients experienced no or Grade 1 cytokine release syndrome (CRS)"

An excessive immune reaction in which the body’s defense system releases large amounts of inflammatory signals (cytokines) all at once, like an overactive alarm system that triggers too many responders and causes collateral damage. It matters to investors because this side effect can halt clinical trials, prompt safety warnings or recalls, and increase development costs and regulatory scrutiny for drugs or therapies, affecting a company’s valuation and future revenue prospects.

immune effector cell-associated neurotoxicity syndrome (icans) medical

"patients experienced no immune effector cell-associated neurotoxicity syndrome (ICANS)"

Immune effector cell-associated neurotoxicity syndrome (ICANS) is a range of brain-related side effects that can occur after treatments that boost or use immune cells (for example some engineered cell therapies). Symptoms can include confusion, trouble speaking, seizures, or decreased consciousness, and severity affects patient safety, treatment guidelines, and regulatory review. Investors care because ICANS can influence a therapy’s approval, labeling, hospital monitoring needs, and overall adoption—similar to how a car recall affects a vehicle’s marketability and ongoing costs.

biologics license application (bla) regulatory

"submitting a Biologics License Application (BLA) for rese-cel in myositis"

A biologics license application (BLA) is a formal request to a government agency seeking approval to sell a biological medicine, such as vaccines or gene therapies, in the market. It is similar to a detailed report that proves the product is safe, effective, and manufactured properly. For investors, a BLA signifies a critical step toward commercial availability, often impacting a company's valuation and market prospects.

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100% (6 of 6) of dermatomyositis patients maintained immunomodulator-free, moderate-to-major TIS responses through one year, with most patients also free of steroids 

100% (5 of 5) of lupus nephritis patients with follow-up from six months to two years achieved immunomodulator-free DORIS remission and evidence of little-to-no disease activity based on repeat kidney biopsies

71% (5 of 7) of systemic sclerosis patients achieved immunomodulator-free rCRISS-50 and the five patients with interstitial lung disease achieved 9% mean FVC improvement, both at one year

71-patient clinical experience with rese-cel following preconditioning reinforces favorable benefit-risk profile across myositis, systemic sclerosis, lupus, and myasthenia gravis

PHILADELPHIA, Nov. 08, 2026 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a late-stage clinical biotechnology company focused on developing and launching curative targeted cell therapies designed specifically for patients with autoimmune diseases, today announced new Phase 1/2 clinical data on resecabtagene autoleucel (rese-cel) to be presented in one oral and two poster presentations at the American College of Rheumatology (ACR) Convergence 2026 annual meeting in Orlando, FL. In addition, Cabaletta will host an industry-supported Innovation Theater symposium highlighting rese-cel as a potential treatment for autoimmune diseases and insights from the RESET™ clinical development program.

“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. “We believe these emerging data reinforce the potential of rese-cel to deliver an immune reset that leads to durable efficacy with a favorable benefit-risk profile for autoimmune disease patients.”

Cabaletta’s presentations highlight follow-up from Phase 1/2 patients treated in open-label, single-arm studies with a single, weight-based infusion of rese-cel following preconditioning as of September 4, 2026, the data cut-off date. Nearly all patients discontinued all immunomodulators and required no or only low-dose steroids while achieving durable improvement in disease activity.

All Six Dermatomyositis Patients Achieved Immunomodulator-Free, Moderate-to-Major TIS Responses At One Year

• 100% (6/6) of patients maintained an immunomodulator-free, moderate-to-major Total Improvement Score (TIS) response through one year, with 83% (5/6) achieving that level as early as Week 16, the timepoint corresponding to the primary endpoint of the ongoing registrational dermatomyositis (DM) and antisynthetase syndrome (ASyS) cohort. Most of these patients were also free of steroids at Week 52.
• Improvements were also seen in disease activity, including muscle strength (MMT-8) and skin manifestations (CDASI-A), as well as in patient-reported outcomes on physical function and fatigue.
  
  

These data will be presented in an oral presentation (Abstract 0902) at 1:00 p.m. ET on Sunday, November 8. Cabaletta anticipates reporting topline results from the registrational adult DM/ASyS cohort in the second half of 2027 and submitting a Biologics License Application (BLA) for rese-cel in myositis, including adult DM and all available juvenile DM Phase 1/2 clinical data, in the first quarter of 2028.

All Five Lupus Nephritis Patients With Repeat Kidney Biopsy Achieved Immunomodulator-Free DORIS Remission and Histologic Response or Remission

• 100% (5/5) of patients who underwent an optional repeat kidney biopsy after rese-cel infusion achieved the definition of remission in systemic lupus erythematosus (DORIS) off all immunomodulators and on no or low-dose steroids.
• 100% (5/5) of biopsied patients demonstrated histologic response or remission.
  
  

These data will be presented in a poster presentation (Abstract 1222) from 10:30 a.m. – 12:30 p.m. ET on Monday, November 9. Cabaletta believes these data provide important insights for assessing clinical responses in lupus nephritis patients who demonstrate histologic response or remission without meeting criteria for complete renal response (CRR), where persistent proteinuria is consistent with structural kidney damage predating treatment rather than ongoing disease activity.

Systemic Sclerosis Patients Sustained Immunomodulator-Free Improvement Across Multiple Measures Through One Year, Including Improved Lung Function

• 71% (5/7) of patients achieved rCRISS-50 at one year, with 86% (6/7) of patients achieving rCRISS-25 at the same timepoint.
• 9% improvement in mean percent-predicted forced vital capacity (FVC) was observed at one year among the five patients with interstitial lung disease.
• Patients also demonstrated improvement as measured by the modified Rodnan Skin Score at one year.
  
  

Additional perspective on these patients and on the broader RESET clinical development program will be shared during Cabaletta’s Innovation Theater, “Designed for Autoimmunity: Rese-cel and the RESET™ Clinical Program,” from 1:30 p.m. – 2:15 p.m. ET on Tuesday, November 10. Given the high unmet need in systemic sclerosis, with one of the highest mortality rates among rheumatological conditions, Cabaletta is enrolling a registrational systemic sclerosis cohort with a focus on interstitial lung disease.

Favorable Benefit-Risk Profile Observed to Date Across 71 Patients Spanning Four Autoimmune Diseases

• 94% (67/71) of patients experienced no or Grade 1 cytokine release syndrome (CRS). Grade 2 CRS was reported in 6% (4/71).
• 96% (68/71) of patients experienced no immune effector cell-associated neurotoxicity syndrome (ICANS).
• No immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS) was reported.
  
  

These data will be presented in a poster presentation (Abstract 1673) from 10:30 a.m. – 12:30 p.m. ET on Monday, November 9. Cabaletta believes the reported benefit-risk profile of rese-cel is reflective of its specific combination of construct and production elements designed to prioritize patient safety, including a fully-human CD19 binder, weight-based dosing, and a standard, well-characterized nine-day manufacturing process.

Additional information can be accessed on the website of the ACR Convergence 2026 annual meeting. Presentation materials can be accessed on the Posters & Publications section of the Company’s website.

About resecabtagene autoleucel (rese-cel) for autoimmune diseases
Rese-cel is an investigational chimeric antigen receptor (CAR) T cell therapy designed to achieve a potential immune reset in patients living with autoimmune diseases. Following a single, weight-based intravenous infusion after discontinuation of immunomodulators, rese-cel has shown the ability to deliver an immune reset, leading to clinical responses that have sustained over time. Cabaletta is evaluating rese-cel across the REstoring SElf-Tolerance (RESET™) clinical development program, which includes multiple single-arm, company-sponsored trials in rheumatology, neurology, and dermatology with disease-specific cohorts designed to evolve directly into registrational studies. Cabaletta is also advancing a program of innovations to broaden and deepen the treatment potential of rese-cel across autoimmune diseases.

About Cabaletta Bio
Cabaletta Bio (Nasdaq: CABA) is a late-stage clinical biotechnology company focused on developing and launching curative targeted cell therapies designed specifically for patients with autoimmune diseases. Cabaletta’s lead product candidate, resecabtagene autoleucel (rese-cel), is an investigational 4-1BB-containing fully human CD19-CAR T cell therapy being advanced across the REstoring SElf-Tolerance (RESET™) clinical development program spanning multiple therapeutic areas, including rheumatology, neurology, and dermatology. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA. For more information, visit www.cabalettabio.com and connect with us on LinkedIn.

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.

Contacts
Investors: investors@cabalettabio.com
Media: media@cabalettabio.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Cabaletta Bio’s rese-cel study show in dermatomyositis?

All six dermatomyositis patients maintained moderate-to-major Total Improvement Score responses without immunomodulators through one year. Five of six reached that response level as early as Week 16, and most were also steroid-free at Week 52.

When does Cabaletta Bio expect rese-cel registrational results and a myositis application?

Cabaletta anticipates adult dermatomyositis/antisynthetase syndrome registrational topline results in the second half of 2027 and a myositis Biologics License Application in the first quarter of 2028. The planned application includes adult dermatomyositis and all available juvenile dermatomyositis Phase 1/2 clinical data.

How does Cabaletta Bio interpret persistent proteinuria after rese-cel treatment for lupus nephritis?

Cabaletta believes persistent proteinuria—protein in urine—can be consistent with pre-existing structural kidney damage rather than ongoing disease activity in patients showing biopsy-based response or remission without meeting complete renal response criteria.