zolacabtagene autoleucel (BMS-986353) / BMS - LARVOL DELTA

B-cell Counts and Inflammation Markers Predicting Prevalence and Severity of Cytokine-Release Syndrome in CAR T-Cell Therapy of Patients with Autoimmune Disease (ACR Convergence 2026) - "Patients from Germany were either treated with autologous CD19 CAR-T in a named patient use program, in the phase 1/2 CASTLE trial, or in a phase 1 trial with BMS-986353...Patients received lymphodepletion (LD) with cyclophosphamide and fludarabine prior to CAR-treatment... Pre-treatment B-cell burden and inflammatory state correlate with risk of CRS occurrence. Simple B-cell counts and interleukin-6 can serve as CRS-prediction biomarkers. Strategies for B-cell depletion and systemic inflammation suppression prior to CAR T therapy could lead to a safer therapy approach.References:1."

CAR T-Cell Therapy • Clinical • Cytokine release syndrome • IO biomarker • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Immunology • Inflammation • Inflammatory Arthritis • Leukemia • Lupus • Myositis • Scleroderma • Systemic Lupus Erythematosus • Systemic Sclerosis • CRP • IL6

CD19 Targeted CAR-T Therapy Improves Clinical Outcomes and Reduces Fibrotic Gene Expression and Immune Cell Colocalization in dcSSc Skin (ACR Convergence 2026) - "We generated a comprehensive single-cell and spatial analysis of skin from individuals with diffuse cutaneous SSc (dcSSc) participating in the Phase 1 trial of Zola-cel, an autologous CD19-targeted CAR-T therapy for those with refractory progressive SSc, including diffuse and limited cutaneous SSc... CD19 cell-targeted CAR-T therapy led to clinically meaningful improvements in mRSS and FVC% predicted in refractory SSc. We found decreased expression of key fibrotic markers in skin fibroblasts alongside clinical skin improvement. We also identified reduced immune cell proximity and enrichment, indicating reduced activity and interactions in these samples."

CAR T-Cell Therapy • Clinical • Clinical data • Immune cell • IO biomarker • Fibrosis • Scleroderma • Systemic Sclerosis • ACTA2 • COL8A1 • SFRP4

Urine Proteomics Reveals Mechanisms of Immune Reprogramming following CD19 CAR T Therapy (Zola-cel) in Systemic Lupus Erythematosus (SLE) (ACR Convergence 2026) - No abstract available

CAR T-Cell Therapy • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Breakfree-SSc: A Study to Compare the Efficacy and Safety of BMS-986353 (Zolacabtagene- Autoleucel / Zola-cel), CD19-CAR T Cells, Versus Standard of Care in Participants With Active Systemic Sclerosis (clinicaltrials.gov) - P3 | N=92 | Not yet recruiting | Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | Initiation date: Aug 2026 ➔ Feb 2027

Trial initiation date • Immunology • Scleroderma • Systemic Sclerosis

CC-97540 in Patients With Antineutrophil Cytoplasmic Antibody-associated Vasculitis (clinicaltrials.gov) - P1/2 | N=12 | Active, not recruiting | Sponsor: Marcela V. Maus, M.D.,Ph.D. | Recruiting ➔ Active, not recruiting | Initiation date: Jul 2026 ➔ Mar 2026

Enrollment closed • Trial initiation date • ANCA Vasculitis • Vasculitis • MPO

BMS paused enrollment in its autoimmune trials testing an autologous CD19-targeted CAR-T, zola-cel (BMS-986353). (FierceBiotech) - "...the company disclosed that the enrollment was paused due to 'transient and reversible inflammatory events.'...'Out of an abundance of caution, we implemented a voluntary pause to review clinical data across our zola-cel program...'We are focused on completing our evaluation and resuming enrollment as quickly as possible.'"

Enrollment status • Immunology • Myasthenia Gravis • Rheumatoid Arthritis • Systemic Lupus Erythematosus • Systemic Sclerosis

CA061-1006: A Study to Evaluate the Safety, Tolerability, Efficacy, and Drug Levels of CC-97540 in Participants With Relapsing Forms of Multiple Sclerosis, Progressive Forms of Multiple Sclerosis or Refractory Myasthenia Gravis (MG) (Breakfree-2) (clinicaltrials.gov) - P1 | N=120 | Active, not recruiting | Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Immunology • Multiple Sclerosis • Myasthenia Gravis

CA061-1001: A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases (Breakfree-1) (clinicaltrials.gov) - P1 | N=270 | Active, not recruiting | Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | Recruiting ➔ Active, not recruiting

Enrollment closed • Immunology • Inflammatory Arthritis • Lupus • Myositis • Rheumatoid Arthritis • Rheumatology • Scleroderma • Systemic Lupus Erythematosus • Systemic Sclerosis

CA061-1011: A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE) (clinicaltrials.gov) - P2 | N=89 | Active, not recruiting | Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | Recruiting ➔ Active, not recruiting

Enrollment closed • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Systemic Lupus Erythematosus

A Safety and Tolerability Study of CC- 97540 (BMS-086353) in Anti-Aquaporin 4 Antibody Positive Neuromyelitis Optica Patients (clinicaltrials.gov) - P1 | N=5 | Not yet recruiting | Sponsor: University of Texas Southwestern Medical Center | Initiation date: Jun 2026 ➔ Sep 2026

Trial initiation date • CNS Disorders • Neuromyelitis Optica Spectrum Disorder • Rare Diseases

Breakfree-SSc: A Study to Compare the Efficacy and Safety of BMS-986353 (Zolacabtagene- Autoleucel / Zola-cel), CD19-CAR T Cells, Versus Standard of Care in Participants With Active Systemic Sclerosis (clinicaltrials.gov) - P3 | N=92 | Recruiting | Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | Initiation date: May 2026 ➔ Aug 2026

Trial initiation date • Immunology • Scleroderma • Systemic Sclerosis

CA0611005: Study of BMS-986353, CD19-CAR T Cells, versus SoC in Participants with Active SSc (Breakfree-SSc) (clinicaltrialsregister.eu) - P2/3 | N=16 | Not yet recruiting | Sponsor: Celgene Corp.

New P2/3 trial • Immunology • Scleroderma • Systemic Sclerosis

Baseline B-cell counts and inflammation markers predicting likelihood and severity of toxicity to CAR T-cell therapy in patients with autoimmune disease (EULAR 2026) - P=N/A, P1, P1/2 | "Most of the patients received lymphodepletion (LD) with cyclophosphamide and fludarabine prior CAR-treatment, one patient received bendamustine...78 (72%) patients received CD19-targeting (zorpocabtagene autoleucel (MB-CART19.1), mivocabtagene autoleucel (KYV-101), or BMS-986353) and 30 (28%) patients received CD19- and BMCA-targeting (co-infusion or dual-targeting CAR-T) therapy...Baseline B-cell counts and interleukin-6 may represent predictive biomarkers for CRS in AID patients treated with CAR T-cells. Strategies for B-cell depletion and better control of systemic inflammation prior to CAR T-cell therapy could improve the tolerability of CAR T-cell therapy."

CAR T-Cell Therapy • Clinical • IO biomarker • Hematological Malignancies • Immunology • Inflammation • Inflammatory Arthritis • Lupus • Myositis • Scleroderma • Systemic Lupus Erythematosus • Systemic Sclerosis • CRP • IL6

Pharmacodynamic and pharmacokinetic activity of zola-cel in autoimmune indications: translational data from the Phase 1 Breakfree-1 study (EULAR 2026) - P1 | "After lymphodepleting chemotherapy(LDC) (3 days of fludarabine [30 mg/m2/day] and cyclophosphamide [300 mg/m2/day]), a single infusion of 10 × 10 6 (recommended dose for phase 2) CAR+ T cells was administered. (A) After LDC, plasmablasts comprised the majority of circulating CD19+ B cells on Day 1.(B) Soluble BCMA levels remained stable during LDC and rapidly decreased following zola-cel infusion for all cohorts (median indicated per indication). (C) Interferon gene signatures associated with autoimmune disease activity were reduced by Day 29 through at least Day 365, despite return of circulating B and T cells in peripheral blood."

IO biomarker • P1 data • PK/PD data • Immunology • Inflammatory Arthritis • Lupus • Myositis • Scleroderma • Systemic Lupus Erythematosus • Systemic Sclerosis • CD20

Breakfree-SSc: A Study to Compare the Efficacy and Safety of BMS-986353 (Zolacabtagene- Autoleucel / Zola-cel), CD19-CAR T Cells, Versus Standard of Care in Participants With Active Systemic Sclerosis (clinicaltrials.gov) - P3 | N=92 | Recruiting | Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Scleroderma • Systemic Sclerosis

A Safety and Tolerability Study of CC- 97540 (BMS-086353) in Anti-Aquaporin 4 Antibody Positive Neuromyelitis Optica Patients (clinicaltrials.gov) - P1 | N=5 | Not yet recruiting | Sponsor: University of Texas Southwestern Medical Center

New P1 trial • CNS Disorders • Neuromyelitis Optica Spectrum Disorder • Rare Diseases

Study of Zola-cel (BMS-986353), in Participants With Autoimmune Cytopenia (Breakfree-AiCE) (clinicaltrials.gov) - P2 | N=52 | Not yet recruiting | Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

New P2 trial • Anemia • Autoimmune Hemolytic Anemia • Hematological Disorders • Immune Thrombocytopenic Purpura • Immunology • Thrombocytopenia • Thrombocytopenic Purpura

CC-97540 in Patients With Antineutrophil Cytoplasmic Antibody-associated Vasculitis (clinicaltrials.gov) - P1/2 | N=12 | Recruiting | Sponsor: Marcela V. Maus, M.D.,Ph.D. | Not yet recruiting ➔ Recruiting

Enrollment open • ANCA Vasculitis • Vasculitis • MPO

Safety and efficacy of CD19 NEX-T® (BMS-986353)—a CD19-directed chimeric antigen receptor (CAR) T cell therapy—for severe refractory systemic lupus erythematosus (SLE): breakfree-1 trial update (LUPUS 2026) - P1, P2 | "Anti-dsDNA autoantibody titers decreased over time.Abstract S15:01 Figures and Table Conclusions These findings demonstrate manageable safety of BMS-986353 and highlight its potential to drive immune reset, leading to sustained drug-free disease control in severe, refractory SLE. Phase 2 Breakfree-SLE trial ( NCT07015983) is currently enrolling patients."

Clinical • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

CA061-1011: Study of CC-97540 (BMS-986353), CD19-CAR T Cells, in Participants with Active SLE Despite Immunosuppressants (Breakfree-SLE) (clinicaltrialsregister.eu) - P1/2 | N=35 | Recruiting | Sponsor: Celgene Corp.

New P1/2 trial • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Systemic Lupus Erythematosus

CD19 NEX-T® (BMS-986353), a Chimeric Antigen Receptor (CAR) T Cell Therapy, for Active SLE With Inadequate Response to Glucocorticoids and at Least 2 Immunosuppressants: a Phase 2 Trial in Progress (LUPUS 2026) - P1, P2 | "An evidence-based historical control group will be used.Results N/A Abstract PO:11:273 Figure 1 Conclusions Breakfree-SLE aims to address key limitations in CAR T cell development for SLE with improved manufacturing, expanded study population to reflect real-world unmet needs, comprehensive disease scoring, and assessment of PROs and durability of response. It represents a meaningful step in generating critical evidence for novel treatment development and potentially sustained drug-free remission in SLE."

P2 data • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Systemic Lupus Erythematosus

SAFETY AND EFFICACY OF CD19 NEX-T® (BMS-986353), A CHIMERIC ANTIGEN RECEPTOR (CAR) T CELL THERAPY, IN SYSTEMIC SCLEROSIS (SSC): FINDINGS FROM THE BREAKFREE-1 TRIAL (SSWC 2026) - P1 | "Eleven of 12 patients with >/=1 month of follow-up remained off SSc-specific IST; 1 patient with low pulmonary reserve at baseline and no clinical worsening received nintedanib. BMS-986353 demonstrated a manageable safety profile and meaningful clinical improvement in patients with severe refractory SSc who remained off IST at follow-up. POSTER"

Clinical • Hematological Disorders • Immunology • Inflammation • Interstitial Lung Disease • Leukopenia • Neutropenia • Pulmonary Disease • Respiratory Diseases • Scleroderma • Systemic Sclerosis

Clinical Outcomes from the Pooled Safety Analysis of CD19 Nex-T™ (BMS-986353), a Chimeric Antigen Receptor (CAR) T cell Therapy Manufactured Using a Next-Generation Process, in Severe Refractory Autoimmune Diseases: Results from Phase 1 Breakfree Studies (TCT-ASTCT-CIBMTR 2026) - P1 | "Introduction BMS-986353 is a CD19 CAR NEX-T cell therapy ( Fig 1 ) that expresses the same CAR as lisocabtagene maraleucel, manufactured via minimally expanded manufacturing process optimized to improve scalability and global patient access. Assess the clinical efficacy of BMS-986353 in reducing disease activity and improving relevant clinical outcomes in severe refractory autoimmune diseases, including reduction in SLEDAI-2K scores for SLE, improvements in mRSS and pFVC for SSc, and increase in MMT-8 scores for IIM. Understand the PK/PD profile of BMS-986353 in patients with severe refractory autoimmune disease, including CAR T cell expansion and peripheral B-cell depletion."

Clinical • Clinical data • P1 data • CNS Disorders • Immunology • Inflammatory Arthritis • Lupus • Multiple Sclerosis • Myasthenia Gravis • Myositis • Scleroderma • Systemic Lupus Erythematosus • Systemic Sclerosis

CC-97540 in Patients With Antineutrophil Cytoplasmic Antibody-associated Vasculitis (clinicaltrials.gov) - P1/2 | N=12 | Not yet recruiting | Sponsor: Marcela V. Maus, M.D.,Ph.D.

New P1/2 trial • ANCA Vasculitis • Vasculitis • MPO

Breakfree-SSc: A Study to Compare the Efficacy and Safety of BMS-986353 (Zolacaptagene- Autoleucel / Zola-cel), CD19-CAR T Cells, Versus Standard of Care in Participants With Active Systemic Sclerosis (clinicaltrials.gov) - P3 | N=92 | Not yet recruiting | Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

New P3 trial • Immunology • Scleroderma • Systemic Sclerosis