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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
Company:
Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology, Miltenyi Biotec
Drug class:
CD19-targeted CAR-T immunotherapy
Related drugs:
Associations
2ms
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
3ms
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
4ms
New trial • Gene therapy
|
MB-CART 19.1 • MB-CART20.1 • zamtocabtagene autoleucel (MB-CART2019.1)
5ms
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
11ms
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
over1year
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
almost3years
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
|
CD19 (CD19 Molecule) • CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
|
CD19 expression
|
cyclophosphamide • fludarabine IV • Actemra IV (tocilizumab) • MB-CART 19.1
3years
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