Cabaletta Bio, Inc. filed a current report on November 9, 2026, disclosing new Phase 1/2 clinical data for rese-cel (resecabtagene autoleucel, formerly known as CABA-201) presented at the American College of Rheumatology Convergence 2026, covering outcomes across four autoimmune diseases.

Key Highlights

  • Dermatomyositis response: 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 by Week 16.
  • Lupus nephritis biopsy findings: 100% (5/5) of patients who underwent an optional repeat kidney biopsy achieved DORIS remission off all immunomodulators, and 100% (5/5) demonstrated histologic response or remission.
  • Systemic sclerosis outcomes: 71% (5/7) of patients achieved rCRISS-50 at one year, and a 9% improvement in mean percent-predicted forced vital capacity (FVC) was observed at one year among patients with interstitial lung disease.
  • Overall safety profile: Across 71 patients spanning four autoimmune diseases, 94% (67/71) experienced no or Grade 1 cytokine release syndrome; 96% (68/71) experienced no immune effector cell-associated neurotoxicity syndrome (ICANS).
  • Regulatory timeline: The company 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 in the first quarter of 2028.
  • Data cut-off date: All follow-up data reported are as of September 4, 2026.

Rese-cel Clinical Results Across Dermatomyositis, Lupus Nephritis, and Systemic Sclerosis

According to the filing, Cabaletta Bio presented rese-cel Phase 1/2 data in one oral and two poster presentations at the American College of Rheumatology Convergence 2026. The data, as of the September 4, 2026 cut-off date, reflect follow-up from patients enrolled in open-label, single-arm studies who received a single, weight-based infusion of rese-cel following preconditioning. The filing states that "nearly all patients discontinued all immunomodulators and required no or only low-dose steroids while achieving durable improvement in disease activity."

In the dermatomyositis cohort, the company disclosed that 100% (6/6) of patients maintained an immunomodulator-free, moderate-to-major TIS response through one year, with improvements also observed in muscle strength (MMT-8) and skin manifestations (CDASI-A). For lupus nephritis, the company disclosed that among the five patients who underwent optional repeat kidney biopsy, all achieved DORIS remission off immunomodulators and all demonstrated histologic response or remission. The filing notes the company's view that "persistent proteinuria is consistent with structural kidney damage predating treatment rather than ongoing disease activity," though the filing characterizes this as the company's own interpretation. For systemic sclerosis, 86% (6/7) of patients achieved rCRISS-25 at one year, and patients also demonstrated improvement in the modified Rodnan Skin Score.

Regarding the benefit-risk profile across all 71 patients in four autoimmune diseases, the filing reports no cases of Grade 3 or higher cytokine release syndrome and no immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS). The company attributed the profile in part to design elements including "a fully-human CD19 binder, weight-based dosing, and a standard, well-characterized nine-day manufacturing process." The filing is listed on NASDAQ:CABA and notes the data were furnished under Item 7.01 Regulation FD Disclosure and are not deemed "filed" for Section 18 liability purposes.

What Was Disclosed

Cabaletta Bio furnished an 8-K on November 9, 2026 disclosing Phase 1/2 clinical data for rese-cel across dermatomyositis, lupus nephritis, and systemic sclerosis, along with a BLA submission target of the first quarter of 2028 for myositis.