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

Aggregate Safety Profile of Rese-cel (Resecabtagene Autoleucel) in Patients with Refractory Autoimmune Diseases (ACR Convergence 2026) - No abstract available

Clinical • Immunology

Histological Remission and Response in Severe and Refractory Lupus Nephritis Patients after Treatment with Rese-cel (Resecabtagene Autoleucel), an Autologous CD19-CAR T Cell Therapy (ACR Convergence 2026) - No abstract available

CAR T-Cell Therapy • Clinical • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology

Durable One-Year Immunomodulatory-Free Clinical Responses Following a Single Infusion of Rese-cel (Resecabtagene Autoleucel) in Refractory Dermatomyositis (ACR Convergence 2026) - P2/3 | "Background/Purpose: Dermatomyositis (DM) is a chronic autoimmune disease requiring long-term immunomodulators (IMs) that carry toxicity risk and often fail to achieve adequate responses; sustained control of disease that is free of ongoing IMs would represent a paradigm shift beyond continuous immunosuppression. In this cohort of adults with severe, refractory DM, a single infusion of rese-cel provided highly meaningful IM-free clinical responses which have been maintained through latest follow-up, including 2 patients through one year, along with an acceptable safety profile. These findings support the potential for CD19 CAR T cell therapy to reset the immune system and enable sustained treatment-free disease control in DM."

Clinical • Immunomodulating • Dermatomyositis • Hematological Disorders • Immunology • Infectious Disease • Myositis • CD20 • CD24

CD19-CAR T cell therapy without lymphodepletion preconditioning (PC-free) in pemphigus vulgaris: Early clinical and translational data with resecabtagene autoleucel, an autologous 4-1BB CD19-CAR T (ESGCT 2026) - No abstract available

CAR T-Cell Therapy • Clinical • Dermatology • Immunology • Pemphigus Vulgaris

RESET-SSc: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T Cell Therapy, in Subjects With Systemic Sclerosis (clinicaltrials.gov) - P2/3 | N=37 | Recruiting | Sponsor: Cabaletta Bio | Phase classification: P1/2 ➔ P2/3 | N=12 ➔ 37

Enrollment change • Phase classification • Immunology • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases • Scleroderma • Systemic Sclerosis

RESET-MG: A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Generalized Myasthenia Gravis (clinicaltrials.gov) - P1/2 | N=24 | Recruiting | Sponsor: Cabaletta Bio | Active, not recruiting ➔ Recruiting | N=12 ➔ 24

Enrollment change • Enrollment open • CNS Disorders • Myasthenia Gravis • LRP4

SSc-associated ILD selected as second registrational cohort to initiate in 4Q26 (GlobeNewswire) - "Based on complete RESET-SSc Phase 1/2 cohort data and FDA feedback, Cabaletta is preparing to conduct a single-arm registrational study in a new cohort of approximately 25 patients with systemic sclerosis (SSc)-associated interstitial lung disease (ILD) using a forced vital capacity-based primary endpoint at 52 weeks."

New trial • Immunology • Interstitial Lung Disease • Systemic Sclerosis

PC-free approach being incorporated in RESET-MG and enrolling in higher-dose cohorts in RESET-PV and RESET-SLE (GlobeNewswire) - "Based on complete RESET-MG Phase 1/2 cohort data shared at the American Academy of Neurology Annual Meeting in April 2026 and emerging insights from the broader preconditioning (PC)-free program for rese-cel, Cabaletta is incorporating dose exploration with PC-free rese-cel in RESET-MG."

Trial status • Immunology • Myasthenia Gravis • Pemphigus Vulgaris • Systemic Lupus Erythematosus

Registrational RESET-Myositis data on track for mid-2027 to support first potential BLA submission for rese-cel in 2H27 (GlobeNewswire) - "Cabaletta continues to anticipate reporting data from the registrational, 17-patient dermatomyositis (DM) and antisynthetase syndrome (ASyS) cohort in mid-2027, including 14 adult DM patients and 3 adult ASyS patients."

FDA filing • P1/2 data • Dermatomyositis • Immunology • Myositis

Safety and Efficacy of rese-cel, an Autologous CD19-CAR T Cell Therapy, in Generalized Myasthenia Gravis (ICNMD 2026) - P1/2 | "Rese-cel (formerly CABA-201) is an investigational, fully human, autologous 4-1BB CD19-CAR T cell therapy, designed to deeply and transiently deplete CD19+B-cells following a single, weight-based infusion, potentially enabling an "immune reset" with durable responses...A single rese-cel infusion of 1x10 6 cells/kg is administered following standard preconditioning with fludarabine and cyclophosphamide... These initial data suggest that rese-cel is well-tolerated and can lead to immune reset in gMG, allowing patients to achieve meaningful clinical responses off of gMG therapies. Both cohorts are fully enrolled, and additional data will be presented at ICNMD."

CAR T-Cell Therapy • Clinical • CNS Disorders • Infectious Disease • Inflammation • Myasthenia Gravis

Resecabtagene autoleucel: “After discontinuation of all immunodulators, 5 of 7 AChR-positive patients showed clinically meaningful improvements on the MG-ADL scale“; Myasthenia gravis (Cabaletta Bio) - Corporate Presentation: "After discontinuation of all immunomodulators, 5 of 6 AChR-negative patients showed clinically meaningful improvements on the MG-ADL scale"

P1/2 data • Immunology • Myasthenia Gravis

CAB-201-005: RESET-MS: A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Multiple Sclerosis (clinicaltrials.gov) - P1/2 | N=0 | Withdrawn | Sponsor: Cabaletta Bio | N=12 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • CNS Disorders • Multiple Sclerosis

RESET-SSc: Phase 1/2 cohort patients showed overall improvement in skin and lung disease activity and achieved clinical responses while off IMs and off or tapering steroids that appear to improve with longer follow-up (GlobeNewswire) - "Patients with ILD at screening demonstrated an IM-free improvement in percent predicted FVC, with a median improvement of 7.5% in patients with 36 weeks of follow-up; 83% (5/6) of patients achieved revised Composite Response Index in Systemic Sclerosis (rCRISS)-25 and 67% (4/6) of patients achieved rCRISS-50 at 36 weeks while off all immunomodulators and off or tapering steroids; 87% (13/15) of patients experienced either no CRS or transient fever (Grade 1 CRS); 93% (14/15) of patients experienced no ICANS (one Grade 3 ICANS previously reported March 2025)."

P1/2 data • Immunology • Systemic Sclerosis

RESET-Myositis: Phase 1/2 cohort data demonstrate 80% (8/10) of dermatomyositis (DM) and antisynthetase syndrome (ASyS) patients would have met the primary endpoint of the registrational cohort. After discontinuation of all immunomodulators (GlobeNewswire) - "83% (5/6) of DM patients achieved an immunomodulator-free (IM-free), moderate-to-major Total Improvement Score (TIS) response at 16 weeks; all patients maintained their IM-free response through latest follow-up as long as 1.5 years; 75% (3/4) of ASyS patients achieved an IM-free, moderate-to-major TIS response at 16 weeks. Durability in these patients was variable, consistent with the reported academic CD19-CAR T data; The first JDM patient achieved an IM-free, moderate TIS response at 16 weeks, with response maintained through latest follow-up at 32 weeks; 100% (17/17) of patients experienced either no CRS or transient fever (Grade 1 CRS) and no immune effector cell-associated neurotoxicity syndrome (ICANS) of any grade was observed in any patient."

P1/2 data • Dermatomyositis • Myositis

RESET-SLE: Based on data from the first two PC-free patients, the lowest dose of PC-free rese-cel appears to be a threshold dose; patients who received rese-cel with preconditioning achieved meaningful clinical responses off IMs with no or low-dose steroids at 12 months (GlobeNewswire) - "One of the two lupus patients experienced deep B cell depletion, similar to what has been observed in lupus patients treated with rese-cel plus preconditioning who achieved an immune reset. The second patient experienced a reduction in peripheral B cells of ~90%....In the preconditioning cohorts: In patients with 12 months of follow-up, 75% (6/8) of patients achieved Definition of Remission in SLE (DORIS) while remaining off IMs for the duration of follow-up; 83% (15/18) of patients remain IM-free and on no or low-dose steroids at latest follow-up. 94% (17/18) of patients experienced either no CRS or transient fever (Grade 1 CRS); 94% (17/18) of patients experienced no ICANS (one Grade 4 ICANS reported in August 2024)."

P1/2 data • Immunology • Systemic Lupus Erythematosus

Safety and Efficacy of Rese-cel (Resecabtagene Autoleucel) in Severe, Refractory Systemic Sclerosis: Results from the Phase 1/2 Cohorts of the RESET-SSc Clinical Trial (EULAR 2026) - P1/2 | "A single weight-based infusion of 1x106 CAR T cells/kg is administered following a preconditioning regimen (fludarabine 25 mg/m2/d on Days -5, -4 and -3, and cyclophosphamide 1,000 mg/m2 on Day -3). These emerging results indicate the potential for rese-cel to reset the immune system in SSc and achieve meaningful clinical responses, including improvements in skin, pulmonary function and nailfold capillaroscopy, while off all background IM therapies. Additional patients and extended follow-up from RESET-SSc will be presented at the EULAR meeting."

Clinical • P1/2 data • Cardiovascular • CNS Disorders • Febrile Neutropenia • Immunology • Infectious Disease • Inflammation • Respiratory Diseases • Scleroderma • Systemic Sclerosis

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) - P1/2, P2/3 | "Over longer follow-up, the observed shift from transitional naïve to mature naïve B cells in a subset of patients demonstrates that the B cell compartment undergoes expected ontologic development following rese-cel infusion. Overall, these findings support rese-cel’s potential to reset the B cell compartment and achieve meaningful, drug-free responses in patients with refractory autoimmune conditions."

IO biomarker • P1/2 data • Immunology • Inflammatory Arthritis • Lupus • Myositis • Systemic Lupus Erythematosus • Systemic Sclerosis • CD20 • CD24

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) - P1/2 | "Patients received a single weight-based infusion of 1×10⁶ CAR T cells/kg following lymphodepletion with fludarabine (25 mg/m²/day on Days –5, –4, and –3) and cyclophosphamide (1,000 mg/m² on Day –3). Overall, these findings support the potential of rese-cel to enable an immune reset and achieve meaningful, drug-free responses in patients with moderate to severe refractory non-renal SLE and LN. Additional patients, potentially some without preconditioning, and extended follow-up from the RESET-SLE trial will be presented at the EULAR meeting."

Clinical • P1/2 data • Glomerulonephritis • Immunology • Infectious Disease • 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) - P2/3 | "A weight-based infusion of 1x106 CAR T cells/kg was given following preconditioning with fludarabine (25 mg/m2/d on days -5, 4 and 3) and cyclophosphamide (1000 mg/m2 on day -3). A Ph 2b study of patients with DM & ASyS has initiated enrollment to further evaluate the efficacy of rese-cel. Additional patients and extended follow-up from RESET-Myositis will be presented at the EULAR meeting."

Clinical • P1/2 data • Dermatomyositis • Febrile Neutropenia • Hematological Disorders • Infectious Disease • Myositis • Neutropenia • Rare Diseases

Anticipated Development Plans and Upcoming Milestones for Rese-cel (GlobeNewswire) - "Initiate SSc registrational program with preconditioning in 4Q26, leveraging Phase 1/2 RESET-SSc data and FDA discussions: Based on the complete Phase 1/2 cohort data and FDA feedback, Cabaletta is conducting a single-arm registrational study of approximately 25 patients with SSc-associated ILD using an FVC-based primary endpoint at 52 weeks. Cabaletta anticipates initiating this study in 4Q26; Report topline data from registrational DM/ASyS cohort in mid-2027: Patient enrollment is progressing in the registrational, single-arm DM/ASyS cohort in RESET-Myositis, which includes an outpatient dosing option; Advance enrollment in JDM to support incorporation in 2H27 BLA submission...Based on the safety profile and unanticipated activity of the lowest PC-free rese-cel dose in lupus and pemphigus vulgaris patients, Cabaletta plans to generate and report dose-ranging data across multiple autoimmune indications."

Clinical data • FDA filing • New trial • Trial status • Dermatomyositis • Lupus • Myositis • Pemphigus Vulgaris • Systemic Sclerosis

CAR T therapy without preconditioning in pemphigus vulgaris: Early clinical and translational data with resecabtagene autoleucel, an autologous 4-1BB CD19-CAR T (ASGCT 2026) - P1/2 | "One patient experienced grade 1 cytokine release syndrome (CRS) 14 days post-infusion that resolved following antipyretics and tocilizumab. 1. PDAI total activity scores (mucosal, skin, and scalp) in the 4 PV patients following rese-cel infusion from baseline up to Week 12."

CAR T-Cell Therapy • Clinical • Dermatology • Hematological Malignancies • Immunology • Pemphigus Vulgaris • CCR7 • CD20 • CD24 • CD8 • IFNG

CD19 CAR T Therapy Is Feasible in Patients with Pemphigus Vulgaris Treated Without Lymphodepletion in the RESET-PV Trial. (PubMed, Blood) - P1/2 | "Here, we report on the early safety, efficacy, and correlative data of the first four pemphigus vulgaris (PV) subjects who received resecabtagene autoleucel (rese-cel) a fully human CD19-CAR T cell therapy, without LD in the RESET-PV® trial (NCT04422912), a sub-study of the DesCAARTes trial...Pathogenic PV autoantibodies decreased in 2 of 4 subjects. Together, these preliminary data suggest that LD may not be required for humanized CAR T efficacy in patients with AD."

Journal • Dermatology • Hematological Disorders • Hematological Malignancies • Immunology • Oncology • Pemphigus Vulgaris

End-to-end fully automated CAR T manufacturing using the Cellares Cell Shuttle Platform: Initial translational data from autoimmune patients treated in RESET trials with rese-cel (Resecabtagene Autoleucel), an autologous 4-1BB CD19-CAR T cell therapy (ASGCT 2026) - P1/2, P2/3 | "Rese-cel is administered at 1x106 CAR T cells/kg administered after preconditioning with fludarabine (25 mg/m2/d on days -5, 4 and 3) and cyclophosphamide (1000 mg/m2 on day -3) in several clinical trials. Conclusion End-to-end implementation of the Cell Shuttle enables lower cost, reproducible manufacturing within pre-specified release criteria that is consistent with historic process data from manually manufactured rese-cel batches. Early translational data of the first patient(s) treated with CAR T manufactured using the Cell Shuttle will be available for presentation at the meeting and findings will be compared to data from patients treated with the existing commercial manufacturing process."

CAR T-Cell Therapy • Clinical • Immunology • Inflammatory Arthritis • Myositis

Single-cell profiling of PBMC subsets following rese-cel (ResecabtageneAutoleucel) treatment across the RESET-Myositis, RESET-SSc, and RESET-SLE trials Phase 1 / 2 Cohorts (ASGCT 2026) - P1/2, P2/3 | "Approximately 24 weeks after rese-cel treatment, multiple immune cell populations— including T cells, neutrophils, and monocytes—exhibit reduced activation and diminished inflammatory signaling signatures. Together, these findings suggest that rese-cel promotes a broadly less inflamed immune milieu following B-cell reconstitution, which is consistent with an immune reset and support rese-cel’s potential to achieve meaningful, drug-free responses in patients with refractory autoimmune conditions."

IO biomarker • Immunology • Inflammatory Arthritis • Lupus • Myositis • Systemic Lupus Erythematosus • Systemic Sclerosis • CCR7 • CD4 • CD8 • CX3CR1 • GNLY • GZMB • IFI16 • IFNB1 • IFNG • IFNGR1 • IL16 • IL32 • JAK2 • TNFRSF14

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) - "Conclusion Product quality and process performance for 74 out of 75 refractory AD patients across CD19-CAR T cell therapy manufacturing platforms was consistent with healthy donors demonstrating robustness to starting material variability. This data suggests low failure rates for manufacturing of engineered T-cell therapies for patients with refractory autoimmune diseases, provides confidence in platform robustness and transferability and enables lower cost of commercial supply resulting from higher frequency of patient delivery per manufacturing run."

Clinical • Immunology • CD28 • CD8 • PTPRC