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    DRUG:

    zolacaptagene autoleucel (BMS-986353)

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

    News

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

    News

    Trials
    21d
    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) • zolacaptagene autoleucel (BMS-986353)
    6ms
    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) • zolacaptagene autoleucel (BMS-986353)
    6ms
    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 • zolacaptagene autoleucel (BMS-986353)
    8ms
    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 • zolacaptagene autoleucel (BMS-986353)
    9ms
    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) • zolacaptagene autoleucel (BMS-986353)
    over1year
    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 • zolacaptagene autoleucel (BMS-986353)
    almost2years
    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, 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
    |
    cyclophosphamide • fludarabine IV • zolacaptagene autoleucel (BMS-986353)
    almost2years
    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, Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | N=43 --> 129
    Enrollment change • CAR T-Cell Therapy
    |
    cyclophosphamide • fludarabine IV • zolacaptagene autoleucel (BMS-986353)
    almost2years
    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, Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | Not yet recruiting --> Recruiting
    Enrollment open
    |
    cyclophosphamide • fludarabine IV • zolacaptagene autoleucel (BMS-986353)
    almost2years
    A Study of CC-97540 in Participants With Severe, Refractory Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov)
    P1, N=43, Recruiting, 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
    |
    cyclophosphamide • fludarabine IV • zolacaptagene autoleucel (BMS-986353)
    2years
    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, Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
    New P1 trial
    |
    cyclophosphamide • fludarabine IV • zolacaptagene autoleucel (BMS-986353)
    over3years
    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=80, Active, not recruiting, Juno Therapeutics, a Subsidiary of Celgene | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
    |
    BCL6 rearrangement • BCL2 rearrangement
    |
    cyclophosphamide • zolacaptagene autoleucel (BMS-986353)