BMS-986353 / BMS - LARVOL DELTA

Promising Early Outcomes With BMS-986353, a CD19-directed Chimeric Antigen Receptor T Cell Therapy in Severe Refractory Idiopathic Inflammatory Myopathies: Safety and Efficacy Findings From the Ongoing Phase 1 Trial (ACR Convergence 2025) - P1 | "All patients discontinued IIM-specific therapies and steroids (≥5 mg prednisone equivalent, except when directed for adrenal insufficiency) before lymphodepletion...One patient had immune effector cell-associated neurotoxicity syndrome (Gr 3) characterized by decreased level of consciousness and aphasia, which resolved in 3 days with dexamethasone... Findings from Breakfree-1 demonstrate a manageable safety profile, robust CAR T cell expansion, complete B-cell depletion, and promising efficacy of BMS-986353 without IIM-directed therapies in >90% of patients with severe refractory IIMs. Medical writing: Sameen Yousaf, PhD (Caudex, an IPG Health company), funded by BMS. Table Figure 1."

CAR T-Cell Therapy • Clinical • Late-breaking abstract • P1 data • Anemia • Endocrine Disorders • Hematological Disorders • Immunology • Infectious Disease • Inflammation • Myositis • Nephrology • Neutropenia • Rare Diseases • Renal Disease

Updated Phase 1 Trial Data Assessing the Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of BMS-986353 (CC-97540), a CD19-directed Chimeric Antigen Receptor T Cell Therapy Using a Next-Generation Process for Severe, Refractory SLE (ACR Convergence 2025) - P1 | "These data show a manageable safety profile and preliminary clinical benefit of BMS-986353 for pts with severe, treatment-resistant SLE, suggesting BMS-986353 may be a potential therapeutic option."

CAR T-Cell Therapy • Clinical • P1 data • PK/PD data • Hematological Disorders • Immunology • Inflammation • Inflammatory Arthritis • Lupus • Neutropenia • Rheumatology • Thrombocytopenia

Efficacy and Safety of BMS-986353, a CD19-Directed Chimeric Antigen Receptor T Cell Therapy Manufactured Using a Next-Generation Process: Updated Data From a Phase 1 Trial in Patients With Systemic Sclerosis (ACR Convergence 2025) - P1 | "Background/Purpose: BMS-986353 (CC-97540) is an investigational CD19-directed T-cell therapy expressing the chimeric antigen receptor (CAR) used in globally-approved lisocabtagene maraleucel; it is manufactured via the NEX-T™ process to shorten manufacturing time and optimize phenotypic attributes. BMS-986353 showed an acceptable safety profile and preliminary meaningful improvement in skin thickening and lung function in pts with severe, refractory SSc. iAEs were grade 1/2 and resolved quickly. Updated safety, efficacy, and translational data will be presented."

CAR T-Cell Therapy • Clinical • P1 data • Hematological Disorders • Immunology • Infectious Disease • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases • Scleroderma • Systemic Sclerosis

Safety and Tolerability of BMS-986353, a CD19-Directed Chimeric Antigen Receptor T Cell Therapy in Relapsing or Progressive Forms of MS: A Phase 1, Single-Arm, Dose-Escalation Study (Breakfree-2) (ECTRIMS 2025) - P1 | "BMS-986353, an investigational CAR T cell therapy, expresses the CD19-directed CAR utilised in FDA-approved lisocabtagene maraleucel...Pts received a single BMS-986353 infusion 2–9 days after lymphodepletion (3-days fludarabine + cyclophosphamide) at dose levels (DL) 1 and 2 (5 or 10 × 106 CAR T cells)... BMS-986353 treatment showed encouraging initial safety in pts with RMS and PMS, with only transient low-grade CRS and no ICANS. Trial enrolment is ongoing. Updated safety and efficacy data will be presented."

CAR T-Cell Therapy • Clinical • P1 data • Hematological Disorders • Inflammation • Neutropenia • CD19

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 | Recruiting | Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | N=144 ➔ 270

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

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

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

Tolerability and Efficacy of BMS-986353 (CC-97540), a CD19-Directed Chimeric Antigen Receptor (CAR) T Cell Therapy Manufactured Using a Next-Generation Process for Systemic Sclerosis: Updated Data From the Phase 1 Breakfree-1 Study (EULAR 2025) - P1, P3 | "Two to 9 days after lymphodepletion (3 days of fludarabine [30 mg/m 2 /day] and cyclophosphamide [300 mg/m 2 /day]), a single infusion of BMS-986353 was administered. BMS-986353, an investigational CD19-directed CAR T cell therapy using the construct of the FDA-approved liso-cel, is manufactured via the NEX-T process, which shortens manufacturing time and optimizes phenotypic attributes of the CAR T cell product. In patients with severe refractory SSc treated with BMS-986353, all CRS events observed were grade 1/2, brief, and reversible, and 1 patient experienced a grade 1 ICANS event, which resolved quickly. Preliminary data suggest promising efficacy in patients with SSc."

Clinical • P1 data • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Inflammatory Arthritis • Interstitial Lung Disease • Lupus • Lymphoma • Myositis • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Pain • Pulmonary Disease • Respiratory Diseases • Scleroderma • Systemic Lupus Erythematosus • Systemic Sclerosis

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

New P2 trial • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Systemic Lupus Erythematosus

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=144 | Recruiting | Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | Trial completion date: Nov 2027 ➔ Aug 2028 | Trial primary completion date: Nov 2027 ➔ Aug 2028

Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Lupus • Myositis • Scleroderma • Systemic Lupus Erythematosus • Systemic Sclerosis

A Phase 1, Multicenter, Single-Arm, Dose-Escalation Study of BMS-986353 (CC-97540), a CD19-Directed Chimeric Antigen Receptor T Cell Therapy Manufactured Using a Next-Generation Process, Evaluating Safety and Tolerability in Patients With Relapsing or Progressive Forms of Multiple Sclerosis (Breakfree-2) (ACTRIMS Forum 2025) - P1 | "BMS-986353 (CC-97540) is an investigational CAR T cell therapy expressing the CD19-directed CAR used in FDA-approved lisocabtagene maraleucel; the NEX-T® manufacturing process shortens manufacturing time and optimizes phenotypic attributes...Two to 9 days after lymphodepletion (3 days of fludarabine and cyclophosphamide), a single BMS-986353 infusion was administered...One pt was a 33-yr-old male diagnosed with RRMS in 2011 with an Expanded Disability Status Scale (EDSS) score at screening of 3.0, whose previous MS treatments included alemtuzumab, glatiramer acetate, interferon beta-1a, fingolimod, natalizumab, ocrelizumab, ofatumumab, and ublituximab... Treatment with BMS-986353 demonstrated promising initial safety in pts with highly active RRMS, with no ICANS observed and 1 pt with transient low-grade CRS. Trial enrollment is ongoing. Updated safety, pharmacokinetic, and translational data will be presented."

CAR T-Cell Therapy • Clinical • P1 data • CNS Disorders • Hematological Disorders • Infectious Disease • Inflammation • Multiple Sclerosis • Neutropenia • Thrombocytopenia • CD19

Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of BMS-986353 (CC-97540), a CD19-Directed Chimeric Antigen Receptor (CAR) T Cell Therapy Manufactured Using a Next-Generation Process, for Severe, Refractory Autoimmune Diseases: Updated Data from Ongoing Phase 1, Multicenter, Open-Label Studies (ASH 2024) - P1, P3 | "Two to 9 d after lymphodepletion (3 d of fludarabine [30 mg/m2/d], cyclophosphamide [300 mg/m2/d]), a single infusion of BMS-986353 was administered...Robust CAR T cell expansion comparable to the RP2D of liso-cel and complete B-cell depletion were observed after BMS-986353 at a dose of 10 x 106 CAR+ T cells despite being 1/10 of the RP2D of liso-cel. The studies continue to enroll pts in all autoimmune indications. Updated safety, efficacy, and translational data will be presented."

Clinical • P1 data • PK/PD data • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • CNS Disorders • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Immunology • Inflammatory Arthritis • Lupus • Lymphoma • Multiple Sclerosis • Myositis • Non-Hodgkin’s Lymphoma • Oncology • Scleroderma • Systemic Lupus Erythematosus • Systemic Sclerosis • CD19

Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of BMS-986353 (CC-97540), a CD19-Directed Chimeric Antigen Receptor (CAR) T Cell Therapy Manufactured Using a Next-Generation Process, for Severe, Refractory Autoimmune Diseases: Updated Data from Ongoing Phase 1, Multicenter, Open-Label Studies (ASH 2024) - P1, P3 | "Two to 9 d after lymphodepletion (3 d of fludarabine [30 mg/m2/d], cyclophosphamide [300 mg/m2/d]), a single infusion of BMS-986353 was administered...Robust CAR T cell expansion comparable to the RP2D of liso-cel and complete B-cell depletion were observed after BMS-986353 at a dose of 10 x 106 CAR+ T cells despite being 1/10 of the RP2D of liso-cel. The studies continue to enroll pts in all autoimmune indications. Updated safety, efficacy, and translational data will be presented."

Clinical • P1 data • PK/PD data • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • CNS Disorders • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Immunology • Inflammatory Arthritis • Lupus • Lymphoma • Multiple Sclerosis • Myositis • Non-Hodgkin’s Lymphoma • Oncology • Scleroderma • Systemic Lupus Erythematosus • Systemic Sclerosis • CD19

A Phase 1, Multicenter, Open-Label Study to Establish the Preliminary Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of CC-97540 (BMS-986353), a CD19-directed CAR T Cell Therapy Manufactured Using a Next-generation Process, for Severe, Refractory Autoimmune Diseases (ACR Convergence 2024) - P1 | "Pts received a single infusion of CC-97540 2–7 days after lymphodepleting chemotherapy (3 days fludarabine [30 mg/m2], cyclophosphamide [300 mg/m2]). Results from first pts indicate promising preliminary safety and efficacy of CC-97540 at low doses. The data also show robust CAR T cell expansion and complete B cell depletion. CC-97540, a NEX-T investigational CD19 CAR T cell product, is a more potent cellular drug product than liso-cel and can be manufactured with a more rapid processing time and greater capacity."

CAR T-Cell Therapy • Clinical • P1 data • PK/PD data • Hematological Disorders • Immunology • Inflammation • Inflammatory Arthritis • Lupus • Renal Disease • CD19

A Study of CC-97540, CD19-targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells, in Subjects With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Juno Therapeutics, a Subsidiary of Celgene | Active, not recruiting ➔ Completed | N=80 ➔ 24 | Trial completion date: Jun 2024 ➔ Feb 2024 | Trial primary completion date: Jun 2024 ➔ Feb 2024

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL2 • BCL6

NEX-T CD19 chimeric antigen receptor (CAR) T-cell therapy CC-97540 (BMS-986353): Preclinical and translational evidence of deep B-cell depletion suitable for study in severe refractory autoimmune diseases (LUPUS 2024) - P1 | "After lymphodepleting chemotherapy (3 days fludarabine [30 mg/m2] and cyclophosphamide [300 mg/m2]), patients receive a single infusion of CC-97540 at 10×106 (dose level [DL] 1) or 25×106 (DL2) CAR T cells. In patients with RR NHL, hypogammaglobulinemia was induced at low CC-97540 doses, indicating that an immune reset and clinical remission may be observed at similar doses in patients with systemic AID like SLE. CC-97540 is being tested in the phase 1, multicenter, open-label study evaluating the safety and tolerability in patients with severe, refractory SLE (NCT05869955)."

Preclinical • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • CD19 • EGFR

A Study to Evaluate the Safety, Tolerability, Efficacy, and Drug Levels of CC-97540 in Participants With Relapsing Forms of Multiple Sclerosis or Progressive Forms of Multiple Sclerosis (clinicaltrials.gov) - P1 | N=98 | Recruiting | Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | Trial completion date: Feb 2027 ➔ Jul 2027 | Trial primary completion date: Feb 2027 ➔ Jul 2027

Trial completion date • Trial primary completion date • CNS Disorders • Multiple Sclerosis

A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases (clinicaltrials.gov) - P1 | N=129 | Recruiting | Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | N=43 ➔ 129

CAR T-Cell Therapy • Enrollment change • Fibrosis • Immunology • Inflammatory Arthritis • Lupus • Myositis • Scleroderma • Systemic Lupus Erythematosus • Systemic Sclerosis

A Study to Evaluate the Safety, Tolerability, Efficacy, and Drug Levels of CC-97540 in Participants With Relapsing Forms of Multiple Sclerosis or Progressive Forms of Multiple Sclerosis (clinicaltrials.gov) - P1 | N=98 | Recruiting | Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Multiple Sclerosis

First SLE patient dosed in CAR T-cell therapy Phase 1 trial (Lupus News Today) - "Some sites in US, Europe currently recruiting participants with severe SLE....The first participant has been treated in a Phase 1 clinical trial testing the CAR T-cell therapy CC-97540 (BMS-986353) in people with severe systemic lupus erythematosus (SLE)....Researchers want to enroll about 43 people in the Phase 1 clinical trial (NCT05869955)."

Trial status • Systemic Lupus Erythematosus

A Study of CC-97540 in Participants With Severe, Refractory Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - P1 | N=43 | Recruiting | Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | Trial completion date: Feb 2028 ➔ Nov 2027 | Trial primary completion date: Feb 2028 ➔ Nov 2027

Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

IT3 Industry Theatre: Nex-T® generation autologous CAR-T Cell Process Development | by Bristol Myers Squibb (EBMT-EHA 2024) - P1 | "These characteristics combined demonstrate the potential of this platform to optimize cell therapy manufacturing.This presentation will focus on providing an overview of the NEX-T® CD19 manufacturing process, phenotypic and functional characterization of the drug product generated using this process, and the innovative measures BMS is pursuing to enable a robust manufacturing platform to accommodate autoimmune diseases."  A phase 1 study of CC-97540/ BMS-986353 (CD19-targeted NEX-T CAR T cells) for the treatment of Severe,Refractory Systemic Lupus Erythematosus (SLE) is currently ongoing (NCT05869955).(1) Mackensen A, Müller F, Mougiakakos D, Böltz S, Wilhelm A, Aigner M, Völkl S, Simon D, Kleyer A, Munoz L, Kretschmann S, Kharboutli S, Gary R, Reimann H, Rösler W, Uderhardt S, Bang H, Herrmann M, Ekici AB, Buettner C, Habenicht KM, Winkler TH, Krönke G, Schett G. Anti-CD19 CAR T cell therapy for refractory systemic lupus..."

CAR T-Cell Therapy • Hematological Disorders • Hematological Malignancies • Immunology • Inflammatory Arthritis • Lupus • Oncology • Systemic Lupus Erythematosus

A Study to Evaluate the Safety, Tolerability, Efficacy, and Drug Levels of CC-97540 in Participants With Relapsing Forms of Multiple Sclerosis or Progressive Forms of Multiple Sclerosis (clinicaltrials.gov) - P1 | N=98 | Not yet recruiting | Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

New P1 trial • CNS Disorders • Multiple Sclerosis

Nex-T TM Cluster of Differentiation 19 (CD19) Chimeric Antigen Receptor (CAR) T-Cell Therapy BMS-986353 (CC-97540): Comparative Analysis of Baseline Patient Data from Trials in Systemic Lupus Erythematosus (SLE) and Relapsed/Refractory Large B-Cell Lymphoma (R/R LBCL) Related to Manufacturability and Potential Safety (ASH 2023) - P1, P2 | "Comparison of baseline pt data from trials in SLE vs R/R LBCL suggests that pts with SLE have traits that predict improved manufacturing success and lower rates/severity of common CAR T-associated toxicities such as cytokine release syndrome (CRS) and neurological events. A key difference between cohorts is the potential for high tumor burden in R/R LBCL which has been previously associated with CAR T toxicity. Our results show marked differences between cohorts for tumor burden surrogate measures (CRP, LDH, Hct), bone marrow function, inflammatory state, and age which we hypothesize may potentially lead to improved CAR T manufacturing success and lower risk of CRS and/or neurological events for patients with autoimmune disorders vs R/R LBCL."

Clinical • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Immunology • Inflammatory Arthritis • Lupus • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Rheumatology • Systemic Lupus Erythematosus

A Study of CC-97540 in Participants With Severe, Refractory Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - P1 | N=43 | Recruiting | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

A Study of CC-97540 in Participants With Severe, Refractory Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - P1 | N=43 | Not yet recruiting | Sponsor: Bristol-Myers Squibb

New P1 trial • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus