Cabaletta Bio Reports Promising Data from RESET Trials for Transformative Autoimmune Therapy

Cabaletta Bio

PHILADELPHIA, PACabaletta Bio, Inc. (Nasdaq: CABA) has unveiled new clinical and translational data from its ongoing RESET-Myositis™, RESET-SLE™, and RESET-SSc™ trials. The findings highlight potential breakthroughs for rese-cel (resecabtagene autoleucel), a novel investigational therapy targeting autoimmune diseases through profound B cell depletion.

Key results from the studies demonstrate strong efficacy in treating myositis, lupus, and systemic sclerosis, with patients achieving significant clinical responses while off immunomodulators and steroids. Across 18 evaluated patients, 94% experienced no or only mild (Grade 1) cytokine release syndrome (CRS), and 89% showed no signs of ICANS (immune effector cell-associated neurotoxicity syndrome).

“These new findings reinforce our belief that a single, weight-based dose of rese-cel leads to deep B cell depletion and compelling clinical outcomes,” said Dr. David J. Chang, Chief Medical Officer at Cabaletta Bio. “Patients are seeking a drug-free, symptom-free life, which is rarely achieved with current therapies. The data indicate rese-cel’s potential to meet this need and transform treatment paradigms for autoimmune diseases.”

Clinical Highlights

RESET-Myositis (Myositis)

  • 7 out of 8 patients achieved a clinically meaningful Total Improvement Score (TIS) while off all immunomodulatory drugs and tapering steroids.
  • Full responses were seen in subtypes such as antisynthetase syndrome (ASyS) and dermatomyositis (DM).
  • Safety data reported mild CRS (Grade 1) in four patients and no ICANS cases.
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RESET-SLE (Systemic Lupus Erythematosus)

  • 7 out of 7 patients achieved clinical remission (DORIS criteria) without immunomodulators or glucocorticoids, including one lupus nephritis (LN) patient who reached complete renal response.
  • Mild CRS was observed in two patients, with one reported ICANS event (Grade 4, previously disclosed).

RESET-SSc (Systemic Sclerosis)

  • Both enrolled patients showed substantial improvement in skin scores (mRSS) after stopping all medication.
  • Sustained clinical responses out to six months were reported, supported by CRISS scores in one patient.
  • No severe safety events, with one mild CRS and one ICANS case reported.
A Promising Mechanism of Action

Rese-cel utilizes a weight-based dose of fully human CD19-CAR T cells designed to transiently and thoroughly deplete B cells critical to the progression of certain autoimmune diseases. By resetting the immune system, rese-cel aims to deliver profound and long-lasting clinical outcomes without requiring ongoing therapy.

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Preliminary translational data revealed peak CAR T cell expansion within two weeks post-infusion, followed by the recovery of naïve B cell populations by approximately two months. Tissue-resident B cell depletion was confirmed through lymph node biopsies, underscoring rese-cel’s depth of activity.

Accelerating Toward Commercialization

Cabaletta Bio’s RESET program is advancing rapidly, with 51 patients enrolled and 24 doses administered as of the end of May 2025. Discussions with the FDA for registrational pathways in systemic lupus erythematosus, systemic sclerosis, and myositis are planned over the next year.

“With accelerating enrollment at over 65 active U.S. clinical sites, we are working toward our goal of launching rese-cel as the first targeted curative therapy for autoimmune diseases,” said Dr. Chang.

The company continues to present its findings at leading medical forums, including the EULAR 2025 Congress. Cabaletta Bio believes the RESET program has the potential to redefine care for patients with autoimmune conditions, providing hope for those seeking long-term, drug-free symptom relief.

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