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    DRUG:

    MB-CART 19.1

    i
    Other names: MB-CART 19.1, MB-CART19.1, Miltenyi CD-19 CAR-T cell therapy
    Associations

    News

    Trials
    Company:
    Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology, Miltenyi Biotec
    Drug class:
    CD19-targeted CAR-T immunotherapy
    Related drugs:
    Associations

    News

    Trials
    3ms
    MB-CART19.1 in Refractory SLE (clinicaltrials.gov)
    P1/2, N=29, Recruiting, Miltenyi Biomedicine GmbH | Not yet recruiting --> Recruiting | Trial completion date: Mar 2027 --> Aug 2027 | Initiation date: Mar 2024 --> Aug 2024 | Trial primary completion date: Mar 2025 --> Aug 2025
    Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date
    |
    MB-CART 19.1
    4ms
    CAR T cell therapy for CD19-positive cancer - phase I clinical trial (ACTRN12621000762853)
    P1, N=25, Recruiting, Metro North Hospital and Health Service | N=15 --> 25
    Enrollment change • CAR T-Cell Therapy
    |
    CD19 (CD19 Molecule)
    |
    cyclophosphamide • MB-CART 19.1
    5ms
    LONGSAFE: Long-Term Follow-up of Patients Treated With Miltenyi Cell and Gene Therapies (clinicaltrials.gov)
    P=N/A, N=40, Recruiting, Miltenyi Biomedicine GmbH
    New trial • Gene therapy
    |
    MB-CART 19.1 • MB-CART20.1 • zamtocabtagene autoleucel (MB-CART2019.1)
    6ms
    MB-CART19.1 r/r CD19+ B-cell Malignancies (BCM) (clinicaltrials.gov)
    P1/2, N=48, Recruiting, Miltenyi Biomedicine GmbH | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial primary completion date
    |
    CD19 (CD19 Molecule)
    |
    MB-CART 19.1
    12ms
    MB-CART19.1 r/r CD19+ B-cell Malignancies (BCM) (clinicaltrials.gov)
    P1/2, N=48, Recruiting, Miltenyi Biomedicine GmbH
    Trial completion date • Trial primary completion date
    |
    CD19 (CD19 Molecule)
    |
    CD19 expression
    |
    MB-CART 19.1
    1year
    CD19-Targeted CAR-T Cells in Refractory Systemic Autoimmune Diseases: A Monocentric Experience from the First Fifteen Patients (ASH 2023)
    Autologous CD19 CAR T cells MB-CART19.1 were produced with the Miltenyi prodigy platform. After leukapheresis on day -13, manufacturing commenced in house and lymphodepletion was started with fludarabine 25 mg/m2/d intravenously (i.v.) on days -5 to -3 and cyclophosphamide 1000 mg/m2/d i.v. on day -3...6/15 patients received tocilizumab... CD19 CAR T cells induce persistent, drug-free remission in three distinct autoantibody dependent AID with very good tolerability. Though hypothetical cure appears possible, longer follow up is needed. This unprecedented drug-free remission is remarkable as B cells functionally reconstitute.
    Clinical • CAR T-Cell Therapy
    |
    CD27 (CD27 Molecule)
    |
    cyclophosphamide • fludarabine IV • Actemra IV (tocilizumab) • MB-CART 19.1
    almost2years
    CD19 T-CAR for Treatment of Children and Young Adults With r/r B-ALL (clinicaltrials.gov)
    P1/2, N=18, Active, not recruiting, Federal Research Institute of Pediatric Hematology, Oncology and Immunology | Trial completion date: Oct 2022 --> Oct 2025
    Trial completion date • CAR T-Cell Therapy
    |
    CD19 (CD19 Molecule)
    |
    CD19 expression
    |
    cytarabine • cyclophosphamide • etoposide IV • dexamethasone • fludarabine IV • Actemra IV (tocilizumab) • MB-CART 19.1
    3years
    MB-CART19.1 r/r CD19+ B-cell Malignancies (BCM) (clinicaltrials.gov)
    P1/2, N=48, Recruiting, Miltenyi Biomedicine GmbH | Trial completion date: Jul 2022 --> Dec 2022 | Trial primary completion date: Jul 2021 --> Aug 2022
    Trial completion date • Trial primary completion date
    |
    CD19 (CD19 Molecule)
    |
    CD19 expression
    |
    MB-CART 19.1
    3years
    A Phase I Open Label Dose Escalation Study of MB-CART19.1 in Relapsed and Refractory CD19+ B Cell Malignancies, Interim Preliminary Results in Pediatric ALL, Adult ALL Including CLL Cohorts (ASH 2021)
    Subjects undergo lymphodepletion with fludarabine (25 mg/m 2 daily for 3 days) and cyclophosphamide (1000 mg/m 2 on day -3)...1 patient experienced grade III CRS and was treated with tocilizumab...Longer follow-up will establish whether treatment results in durable responses. The hybrid manufacturing model provides flexibility and a timely delivery of the fresh drug product to the patients
    Clinical • P1 data
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    CD19 (CD19 Molecule) • CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
    |
    CD19 expression
    |
    cyclophosphamide • fludarabine IV • Actemra IV (tocilizumab) • MB-CART 19.1
    over3years
    CAR T cell therapy for CD19-positive cancer - phase I clinical trial (ACTRN12621000762853)
    P1, N=9, Not yet recruiting, Metro North Hospital and Health Service
    Clinical • New P1 trial • CAR T-Cell Therapy
    |
    CD19 (CD19 Molecule)
    |
    CD19 positive • CD19 expression
    |
    MB-CART 19.1
    over3years
    CD19 T-CAR for Treatment of Children and Young Adults With r/r B-ALL (clinicaltrials.gov)
    P1/2, N=18, Active, not recruiting, Federal Research Institute of Pediatric Hematology, Oncology and Immunology | Recruiting --> Active, not recruiting | Trial completion date: Mar 2023 --> Oct 2022 | Trial primary completion date: Mar 2023 --> Oct 2020
    Clinical • Enrollment closed • Trial completion date • Trial primary completion date • CAR T-Cell Therapy
    |
    CD19 (CD19 Molecule)
    |
    CD19 expression
    |
    fludarabine IV • Actemra IV (tocilizumab) • MB-CART 19.1 • cyclophosphamide intravenous
    over4years
    MB-CART19.1 r/r CD19+ B-cell Malignancies (BCM) (clinicaltrials.gov)
    P1/2, N=48, Recruiting, Miltenyi Biomedicine GmbH | Trial completion date: Jul 2020 --> Jul 2022 | Trial primary completion date: Jul 2020 --> Jul 2021
    Clinical • Trial completion date • Trial primary completion date
    |
    CD19 (CD19 Molecule)
    |
    CD19 expression
    |
    MB-CART 19.1