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    DRUG:

    zamtocabtagene autoleucel (MB-CART2019.1)

    i
    Other names: MB-CART2019.1, CD2019-targeting CAR T cells, Anti-CD2019 CAR T cells, Zamto-Cel
    Associations

    News

    Trials
    Company:
    Miltenyi Biotec
    Drug class:
    CD19-targeted CAR-T immunotherapy, CD20-targeted CAR-T immunotherapy
    Related drugs:
    Associations

    News

    Trials
    13d
    MB-CART2019.1 in Refractory Multiple Sclerosis (clinicaltrials.gov)
    P1/2, N=26, Not yet recruiting, Miltenyi Biomedicine GmbH | Initiation date: Oct 2025 --> Jan 2026
    Trial initiation date
    |
    zamtocabtagene autoleucel (MB-CART2019.1)
    2ms
    CNS infiltration by zamtocabtagene autoleucel tandem CD20/CD19 CAR T cells leading to complete remission in a patient with primary CNS lymphoma. (PubMed, Haematologica)
    Not available.
    Journal
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    zamtocabtagene autoleucel (MB-CART2019.1)
    2ms
    DALY PED: Safety and Efficacy Study of Zamtocabtagene Autoleucel (MB-CART2019.1) in Pediatric Patients With Relapsed or Refractory B-Cell Neoplasms (clinicaltrials.gov)
    P2, N=31, Recruiting, Miltenyi Biomedicine GmbH | Not yet recruiting --> Recruiting
    Enrollment open
    |
    zamtocabtagene autoleucel (MB-CART2019.1)
    3ms
    MB-CART2019.1 in Refractory Multiple Sclerosis (clinicaltrials.gov)
    P1/2, N=26, Not yet recruiting, Miltenyi Biomedicine GmbH
    New P1/2 trial
    |
    zamtocabtagene autoleucel (MB-CART2019.1)
    6ms
    Safety of MB-CART2019.1 in Lymphoma Patients (MB-CART2019.1 Lymphoma / DALY 1) (clinicaltrials.gov)
    P1, N=12, Completed, Miltenyi Biomedicine GmbH | Phase classification: P1/2 --> P1
    Phase classification
    |
    BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
    |
    zamtocabtagene autoleucel (MB-CART2019.1)
    7ms
    DALY PED: Safety and Efficacy Study of Zamtocabtagene Autoleucel (MB-CART2019.1) in Pediatric Patients With Relapsed or Refractory B-Cell Neoplasms (clinicaltrials.gov)
    P2, N=31, Not yet recruiting, Miltenyi Biomedicine GmbH | Trial completion date: Oct 2029 --> Dec 2029 | Initiation date: Apr 2025 --> Jul 2025 | Trial primary completion date: Sep 2029 --> Dec 2029
    Trial completion date • Trial initiation date • Trial primary completion date
    |
    zamtocabtagene autoleucel (MB-CART2019.1)
    8ms
    DALY II USA/ MB-CART2019.1 for DLBCL (clinicaltrials.gov)
    P2, N=248, Recruiting, Miltenyi Biomedicine GmbH | N=110 --> 248 | Trial completion date: Dec 2026 --> Dec 2028 | Trial primary completion date: Dec 2024 --> Dec 2026
    Enrollment change • Trial completion date • Trial primary completion date
    |
    cyclophosphamide • bendamustine • fludarabine IV • zamtocabtagene autoleucel (MB-CART2019.1)
    1year
    DALY 2-EU: Efficacy and Safety of MB-CART2019.1 vs. SoC in Lymphoma Patients (clinicaltrials.gov)
    P2, N=168, Active, not recruiting, Miltenyi Biomedicine GmbH | Trial completion date: Jul 2027 --> Jul 2029
    Trial completion date
    |
    BCL2 (B-cell CLL/lymphoma 2) • CD19 (CD19 Molecule) • BCL6 (B-cell CLL/lymphoma 6)
    |
    CD19 expression • BCL6 rearrangement • BCL2 rearrangement
    |
    gemcitabine • Rituxan (rituximab) • oxaliplatin • bendamustine • Polivy (polatuzumab vedotin-piiq) • zamtocabtagene autoleucel (MB-CART2019.1)
    1year
    US Zamto-cel Autoimmune Diseases (clinicaltrials.gov)
    P1, N=48, Not yet recruiting, Miltenyi Biomedicine GmbH
    New P1 trial
    |
    cyclophosphamide • fludarabine IV • zamtocabtagene autoleucel (MB-CART2019.1)
    1year
    Lentiviral Gene Therapy (Zamtocabtagene Autoleucel) LTFU (clinicaltrials.gov)
    P=N/A, N=150, Recruiting, Miltenyi Biomedicine GmbH | Not yet recruiting --> Recruiting
    Enrollment open • Gene therapy
    |
    zamtocabtagene autoleucel (MB-CART2019.1)
    1year
    Sustained drug-free remission in rheumatoid arthritis associated with diffuse large B-cell lymphoma following tandem CD20-CD19-directed non-cryopreserved CAR-T cell therapy using zamtocabtagene autoleucel. (PubMed, RMD Open)
    We report the case of long-term persisting rheumatoid arthritis (RA), treated with CD20-CD19 CAR-T when it became associated with diffuse large B cell lymphoma (DLBCL), resulting in a sustained drug-free remission of the preceding RA, as well as of the subsequent DLBCL that formed the indication of the CAR-T therapy using zamtocabtagene autoleucel, with a 1-year follow-up. According to our best knowledge, this is the first published clinical case report of long-term persisting RA treated with CAR-T cell therapy.
    Journal • CAR T-Cell Therapy
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    zamtocabtagene autoleucel (MB-CART2019.1)
    over1year
    DALY 2-EU: Efficacy and Safety of MB-CART2019.1 vs. SoC in Lymphoma Patients (clinicaltrials.gov)
    P2, N=168, Active, not recruiting, Miltenyi Biomedicine GmbH | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    BCL2 (B-cell CLL/lymphoma 2) • CD19 (CD19 Molecule) • BCL6 (B-cell CLL/lymphoma 6)
    |
    gemcitabine • Rituxan (rituximab) • oxaliplatin • bendamustine • Polivy (polatuzumab vedotin-piiq) • zamtocabtagene autoleucel (MB-CART2019.1)