resecabtagene autoleucel (CABA-201) / Cabaletta Bio, IASO BIO - LARVOL DELTA

First clinical experience using automated Cellares manufacturing platform expected in 1H26 (The Manila Times) - "The initial clinical experience is intended to confirm current Good Manufacturing Practice (GMP) readiness, including supply chain logistics, for Cellares-produced rese-cel implementation across the rese-cel portfolio....If successful, the Cellares Integrated Development and Manufacturing Organization (IDMO) Smart Factory has the potential to enable scalability to produce rese-cel for thousands of patients per year with minimal capital investment, lower manufacturing costs through decreased labor requirements with improved scheduling flexibility after commercialization and rapid expansion to global capacity."

Clinical data • Immunology

No-preconditioning program advancing in RESET-SLE and RESET-PV (The Manila Times) - "Clinical data from patients treated with a single weight-based dose of rese-cel with no preconditioning are expected from the RESET-SLE trial in 1H26 (initial data) and 2H26 (durability data). Additionally, dose-ranging durability data from the RESET-PV trial are anticipated throughout 2026, supplementing the initial low dose PV data without preconditioning that were previously presented."

P1/2 data • Lupus Nephritis • Pemphigus Vulgaris • Systemic Lupus Erythematosus

Complete Phase 1/2 data anticipated from three RESET trials to be presented in 1H26 (The Manila Times) - "In RESET-MG, data will be presented in an oral presentation at 1:24 p.m. CDT on Monday, April 20, 2026, at the American Academy of Neurology (AAN) Annual Meeting in Chicago, IL. Complete Phase 1/2 clinical data from cohorts in RESET-SLE and RESET-SSc are also expected in 1H26. These clinical data are expected to support Cabaletta’s discussions with the FDA on potential registrational pathways specifically in RESET-SSc and RESET-MG. Cabaletta anticipates providing an update regarding registrational designs for RESET-SSc in 1H26 and for RESET-MG in mid-2026."

Clinical protocol • P1/2 data • Lupus Nephritis • Myasthenia Gravis • Systemic Lupus Erythematosus • Systemic Sclerosis

Registrational DM/ASyS cohort in RESET-Myositis enrolling with outpatient dosing option (The Manila Times) - "The registrational dermatomyositis (DM) and antisynthetase syndrome (ASyS) cohort is enrolling and is expected to evaluate 17 patients with a 16-week primary endpoint of moderate or major total improvement score response while off immunomodulators and on no or low-dose steroids. If successful, data from this cohort will support Cabaletta’s first projected Biologics License Application (BLA) submission for rese-cel in myositis in 2027."

FDA filing • Trial status • Dermatomyositis

Single-cell profiling of PBMC subsets following rese-cel (Resecabtagene Autoleucel) treatment across the RESET-Myositis, RESET-SSc, and RESET-SLE trials Phase 1 / 2 Cohorts (ASGCT 2026) - No abstract available

Immunology • Inflammatory Arthritis • Myositis • Systemic Sclerosis

Product quality for Resecabtagene autoleucel between healthy donors and autoimmune patients in the RESET clinical trial program starting material is consistent and platform agnostic demonstrating manufacturing robustness (ASGCT 2026) - No abstract available

Clinical • Immunology

Phenotypic and genotypic characterization of peripheral B cell reconstitution following rese-cel (Resecabtagene Autoleucel) infusion and transient B cell depletion across the RESET- Myositis, RESET-SSc, and RESET-SLE trial Phase 1/2 Cohorts (EULAR 2026) - No abstract available

P1/2 data • Immunology • Inflammatory Arthritis • Myositis • Systemic Sclerosis

Safety and Efficacy of Rese-cel (Resecabtagene Autoleucel) in Severe, Refractory SLE and Lupus Nephritis: Results from the RESET-SLE Clinical Trial Phase 1/2 Cohorts (EULAR 2026) - No abstract available

Clinical • P1/2 data • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology

Safety and Efficacy of Rese-cel (Resecabtagene Autoleucel) in Severe, Refractory Idiopathic Inflammatory Myopathy: Results from the Phase 1/2 cohorts of the RESET-IIM Clinical Trial (EULAR 2026) - No abstract available

Clinical • P1/2 data • Myositis

RESET-MG: Clinical Trial Evaluating Rese-cel (Resecabtagene Autoleucel), a Fully Human, Autologous 4-1BB-CD19-CAR T Cell Therapy in Generalized Myasthenia Gravis (gMG) (AAN 2026) - P1/2 | "These initial data suggest that rese-cel is well-tolerated and can cause immune reset in gMG, allowing patients to achieve meaningful clinical responses off gMG therapies. Both cohorts are fully enrolled, with post-treatment data forthcoming."

CAR T-Cell Therapy • Clinical • IO biomarker • CNS Disorders • Inflammation • Myasthenia Gravis • CD24

RESET-SSC: CLINICAL TRIAL EVALUATING RESE-CEL (RESECABTAGENE AUTOLEUCEL), A FULLY HUMAN, AUTOLOGOUS 4-1BB CD19-CAR T CELL THERAPY IN SYSTEMIC SCLEROSIS (SSWC 2026) - P1/2 | "1x10^6 CAR T cells/ kg was administered following preconditioning with fludarabine and cyclophosphamide. Data in SSc patients infused with rese-cel show early IM-free clinical response and acceptable safety profile following rese-cel expansion and complete peripheral and lymph node B cell depletion. These data suggest the potential for rese-cel to reset the immune system in SSc, allowing patients to achieve meaningful clinical responses off IM therapies."

CAR T-Cell Therapy • Clinical • CNS Disorders • Epilepsy • Immunology • Inflammation • Scleroderma • Systemic Sclerosis • CD20 • CD24

RESET-SSC: CLINICAL TRIAL EVALUATING RESE-CEL (RESECABTAGENE AUTOLEUCEL), A FULLY HUMAN, AUTOLOGOUS 4-1BB CD19-CAR T CELL THERAPY IN SYSTEMIC SCLEROSIS (SSWC 2026) - P1/2 | "1x10^6 CAR T cells/ kg was administered following preconditioning with fludarabine and cyclophosphamide. Data in SSc patients infused with rese-cel show early IM-free clinical response and acceptable safety profile following rese-cel expansion and complete peripheral and lymph node B cell depletion. These data suggest the potential for rese-cel to reset the immune system in SSc, allowing patients to achieve meaningful clinical responses off IM therapies."

CAR T-Cell Therapy • Clinical • CNS Disorders • Epilepsy • Immunology • Inflammation • Scleroderma • Systemic Sclerosis • CD20 • CD24

RESET SLE: Clinical Trial Evaluating Rese-cel (Resecabtagene Autoleucel), a Fully Human, Autologous 4-1BB Anti-CD19 CAR T Cell Therapy in Non-Renal SLE and Lupus Nephritis (LN) (LUPUS 2026) - P1/2 | "Transitional naive B cells (CD19+CD20+CD24++CD38++) began to repopulate 1-3 months post-infusion.Abstract PO:11:274 Table 1–2 Conclusions These initial data suggest that rese-cel has a favorable safety profile and has the potential to reset the immune system in SLE/LN, allowing patients to achieve meaningful clinical responses off SLE therapies. Both cohorts are fully enrolled, with additional post-treatment data forthcoming."

CAR T-Cell Therapy • Clinical • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • CD20 • CD24

RESET-MG: A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Generalized Myasthenia Gravis (clinicaltrials.gov) - P1/2 | N=12 | Active, not recruiting | Sponsor: Cabaletta Bio | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Myasthenia Gravis • LRP4

RESET-Myositis: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy (clinicaltrials.gov) - P2/3 | N=74 | Recruiting | Sponsor: Cabaletta Bio | Phase classification: P1/2 ➔ P2/3 | N=24 ➔ 74

Enrollment change • Phase classification • Dermatomyositis • Immunology • Myositis • Rare Diseases

IND Amendment Clearance Obtained for Clinical Manufacturing of Rese-Cel from Cabaletta Bio Using Cellares’ Automated Platforms (Businesswire) - "The clearance allows for the clinical manufacturing and release of rese-cel using Cellares’ fully automated end-to-end manufacturing and high-throughput quality control platforms, with first patient dosing anticipated in the first half of 2026. This milestone marks the Cell Shuttle and Cell Q platforms’ first use to support an active clinical program....'Initial clinical data is anticipated in 1H26 to inform GMP readiness, including supply chain logistics.'"

Clinical data • IND • New trial • Immunology

Complete Phase 1/2 data readouts across three RESET trials expected in 1H26 (GlobeNewswire) - "Following the presentation of complete Phase 1/2 clinical data from RESET-Myositis cohorts in 2025, Cabaletta anticipates complete Phase 1/2 clinical data from cohorts in RESET-SLE, RESET-SSc and RESET-MG in 1H26."

P1/2 data • Dermatomyositis • Lupus Nephritis • Myasthenia Gravis • Myositis • Systemic Lupus Erythematosus • Systemic Sclerosis

Expand the clinical experience of rese-cel and in combination with process innovations to deliver an industry-leading therapy for patients and physicians (GlobeNewswire) - "No preconditioning dose-escalation ongoing in RESET-PV...Additional durability data from patients dosed at the initial dose and initial clinical data from patients dosed at the higher dose are expected in 1H26...No preconditioning cohort added in RESET-SLE...Pending dose-ranging clinical data anticipated in 2026, Cabaletta will evaluate pursuing alignment with the FDA on a registrational pathway for the no preconditioning cohort."

P1/2 data • Trial status • Lupus Nephritis • Pemphigus Vulgaris • Systemic Lupus Erythematosus

Translate registrational pathways with rese-cel into a pipeline in a product across autoimmune diseases (GlobeNewswire) - "Cabaletta has aligned with the FDA on registrational cohort designs in RESET-SLE...Cabaletta will provide an update on next steps for these cohorts later this year subject to dose-ranging data evaluating rese-cel without preconditioning in lupus patients....Cabaletta is continuing to engage with the FDA to align on registrational cohort designs for RESET-SSc and anticipates providing an update regarding registrational alignment for RESET-SSc in 1H26 and RESET-MG in mid-2026."

Trial status • Lupus Nephritis • Myasthenia Gravis • Systemic Lupus Erythematosus • Systemic Sclerosis

A Phase 1/2, Open-label, Safety and Dosing Study of Autologous CART Cells (Desmoglein 3 Chimeric Autoantibody Receptor T Cells [DSG3-CAART] or CD19-specific Chimeric Antigen Receptor T Cells [CABA-201]) in Subjects With Active, Pemphigus Vulgaris (RESET-PV) (clinicaltrials.gov) - P1/2 | N=40 | Recruiting | Sponsor: Cabaletta Bio | Phase classification: P1 ➔ P1/2

Phase classification • Dermatology • Immunology • Pemphigus Vulgaris

Mechanistic basis of the acute safety profile of rese-cel, an autologous CD19-CAR T, in patients with autoimmune disease treated in four ongoing phase 1/2 clinical trials (ASH 2025) - P1/2 | "Here, we provide novel insight into the mechanism underlying the safetyprofile of resecabtagene autoleucel (rese-cel) an autologous CD19 41BBz CART therapy across fourseparate Phase I/II clinical trials in SLE, IIM, SSc, & MG.Objectives: The primary objective of each trial is safety & tolerability of rese-cel at Day 29...Patients were not given prophylactic tocilizumab pre-infusion... Rese-cel appears to be well tolerated in autoimmune patients with rates of CRS & ICANS of37% & 11% across all autoimmune indications, respectively (SLE patients had a 25% CRS rate & 12.5%ICANS rate, IIM patients had a 50% CRS rate & 0% ICANS rate, SSC patients had a 50% CRS & 50% ICANSrate, & MG patients had a 0% CRS & ICANS rate). Notably, the frequency & severity of CRS appears to below, with no CRS in 63% of patients (12/19) & most CRS events (6/7) being Grade 1. The lower frequency& severity of both CRS & ICANS events are likely..."

Clinical • P1/2 data • CNS Disorders • Immunology • Inflammatory Arthritis • Lupus • Myasthenia Gravis • Myositis • Scleroderma • Systemic Lupus Erythematosus • Systemic Sclerosis • CD24 • CD38 • CD8 • CXCL8 • IFNG • IL6

RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus Erythematosus (clinicaltrials.gov) - P1/2 | N=28 | Recruiting | Sponsor: Cabaletta Bio | N=12 ➔ 28 | Trial completion date: Dec 2027 ➔ Dec 2029 | Trial primary completion date: Dec 2027 ➔ Dec 2029

Enrollment change • Trial completion date • Trial primary completion date • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Systemic Lupus Erythematosus

Cabaletta Bio's (CABA) innovative therapy for myasthenia gravis, known as resecabtagene autoleucel, has secured orphan drug designation from the U.S. Food and Drug Administration (FDA) (Gurufocus)

Orphan drug • Myasthenia Gravis

Additional clinical data from RESET trials expected throughout 2026 (GlobeNewswire) - "On December 6, 2025, Cabaletta will present a poster...In addition, Cabaletta plans to present complete Phase 1/2 data from the RESET-SSc and RESET-SLE trials in the first half of 2026 and from the RESET-MG trial in the second half of 2026. The Company also anticipates clinical data on rese-cel without preconditioning from the initial RESET-SLE dose-escalation cohort and additional dosing from the RESET-PV trial in 2026."

P1/2 data • Myasthenia Gravis • Pemphigus Vulgaris • Systemic Lupus Erythematosus • Systemic Sclerosis

FDA alignment on additional registrational cohort designs expected through 2026 (GlobeNewswire) - "Cabaletta expects to align with the FDA on key registrational design elements for the RESET-SSc and RESET-SLE trials by year-end 2025 and for the RESET-MG trial in the first half of 2026. Subject to clinical data and regulatory alignment on registrational cohort design elements for these trials, the Company expects to initiate enrollment in registrational cohorts in 2026."

Trial status • Myasthenia Gravis • Systemic Lupus Erythematosus • Systemic Sclerosis