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    DRUG:

    zolacabtagene autoleucel (BMS-986353)

    i
    Other names: CD19-NEX-T, Zola-cel, BMS-986353, CC-97540, NEX T CD19, CD19 NEX T
    Associations

    News

    Trials
    Company:
    BMS
    Drug class:
    CD19-targeted CAR-T immunotherapy
    Related drugs:
    Associations

    News

    Trials
    2ms
    CA0611005: Study of BMS-986353, CD19-CAR T Cells, versus SoC in Participants with Active SSc (Breakfree-SSc) (2025-524337-11-00)
    P2/3, N=16, Not yet recruiting, Celgene Corp.
    New P2/3 trial
    |
    Rituxan (rituximab) • cyclophosphamide • nintedanib • fludarabine IV • Actemra IV (tocilizumab) • zolacabtagene autoleucel (BMS-986353)
    2ms
    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, Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | Initiation date: May 2026 --> Aug 2026
    Trial initiation date
    |
    Rituxan (rituximab) • cyclophosphamide • nintedanib • fludarabine IV • Actemra IV (tocilizumab) • zolacabtagene autoleucel (BMS-986353)
    3ms
    Study of Zola-cel (BMS-986353), in Participants With Autoimmune Cytopenia (Breakfree-AiCE) (clinicaltrials.gov)
    P2, N=52, Not yet recruiting, Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
    New P2 trial
    |
    cyclophosphamide • fludarabine IV • zolacabtagene autoleucel (BMS-986353)
    3ms
    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, Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Rituxan (rituximab) • cyclophosphamide • nintedanib • fludarabine IV • Actemra IV (tocilizumab) • zolacabtagene autoleucel (BMS-986353)
    3ms
    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, University of Texas Southwestern Medical Center
    New P1 trial
    |
    cyclophosphamide • fludarabine IV • Actemra IV (tocilizumab) • zolacabtagene autoleucel (BMS-986353)
    6ms
    CA061-1011: Study of CC-97540 (BMS-986353), CD19-CAR T Cells, in Participants with Active SLE Despite Immunosuppressants (Breakfree-SLE) (2024-519278-37-00)
    P1/2, N=35, Recruiting, Celgene Corp.
    New P1/2 trial
    |
    cyclophosphamide • fludarabine IV • Actemra IV (tocilizumab) • zolacabtagene autoleucel (BMS-986353)
    7ms
    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, Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
    New P3 trial
    |
    Rituxan (rituximab) • cyclophosphamide • nintedanib • fludarabine IV • Actemra IV (tocilizumab) • zolacabtagene autoleucel (BMS-986353)
    12ms
    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, Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | N=144 --> 270
    Enrollment change
    |
    cyclophosphamide • fludarabine IV • Actemra IV (tocilizumab) • zolacabtagene autoleucel (BMS-986353)
    1year
    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, Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | Not yet recruiting --> Recruiting
    Enrollment open
    |
    cyclophosphamide • fludarabine IV • zolacabtagene autoleucel (BMS-986353)
    1year
    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, Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
    New P2 trial
    |
    cyclophosphamide • fludarabine IV • zolacabtagene autoleucel (BMS-986353)
    over1year
    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, 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
    |
    cyclophosphamide • fludarabine IV • Actemra IV (tocilizumab) • zolacabtagene autoleucel (BMS-986353)
    2years
    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, 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
    Trial completion • Enrollment change • Trial completion date • Trial primary completion date
    |
    BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
    |
    BCL6 rearrangement • BCL2 rearrangement
    |
    cyclophosphamide • zolacabtagene autoleucel (BMS-986353)