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CC-97540

DRUG5 trials

Sponsors

Juno Therapeutics, a Subsidiary of Celgene, Juno Therapeutics, Inc., a Bristol-Myers Squibb Company, Marcela V. Maus, M.D.,Ph.D.

Conditions

Agressive LymphomaAntineutrophil Cytoplasmic Antibody-associated VasculitisDiffuse-large B-cell Lymphoma (DLBCL)Idiopathic Inflammatory MyopathyLupus Erythematosus, SystemicLupus NephritisLymphoma Non-HodgkinMultiple Sclerosis

Phase 1

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
CompletedNCT04231747
Juno Therapeutics, a Subsidiary of CelgeneAgressive Lymphoma, Diffuse-large B-cell Lymphoma (DLBCL), Lymphoma Non-Hodgkin
Start: 2020-05-21End: 2024-02-01Updated: 2024-05-20
A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases (Breakfree-1)
Active, not recruitingNCT05869955
Juno Therapeutics, Inc., a Bristol-Myers Squibb CompanyIdiopathic Inflammatory Myopathy, Rheumatoid Arthritis, Systemic Lupus Erythematosus +1
Start: 2023-09-13End: 2028-08-29Target: 270Updated: 2026-08-03
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)
Active, not recruitingNCT06220201
Juno Therapeutics, Inc., a Bristol-Myers Squibb CompanyMultiple Sclerosis, Myasthenia Gravis
Start: 2024-03-28End: 2027-07-15Target: 120Updated: 2026-08-03
CC-97540 in Patients With Antineutrophil Cytoplasmic Antibody-associated Vasculitis
Active, not recruitingNCT07388277
Marcela V. Maus, M.D.,Ph.D.Antineutrophil Cytoplasmic Antibody-associated Vasculitis
Start: 2026-03-30End: 2029-12-31Target: 12Updated: 2026-09-10

Phase 2

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)
Active, not recruitingNCT07015983
Juno Therapeutics, Inc., a Bristol-Myers Squibb CompanyLupus Erythematosus, Systemic, Lupus Nephritis
Start: 2025-07-14End: 2032-06-15Target: 89Updated: 2026-08-03

Related Papers

CAR T cells for multiple sclerosis: Engineering T cells to disrupt chronic B cell-driven neuroinflammation.
2025-10-261 citations
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
Blood2024-11-052 citations
P105 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
Poster presentations2024-03-012 citations
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
Blood2023-11-02