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DRUG:

zamtocabtagene autoleucel (MB-CART2019.1)

i
Other names: CD2019-targeting CAR T cells, MB-CART2019.1, Anti-CD2019 CAR T cells
Associations
Company:
Miltenyi Biotec
Drug class:
CD19-targeted CAR-T immunotherapy, CD20-targeted CAR-T immunotherapy
Related drugs:
Associations
2d
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
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zamtocabtagene autoleucel (MB-CART2019.1)
28d
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
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CD20 (Membrane Spanning 4-Domains A1)
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zamtocabtagene autoleucel (MB-CART2019.1)
4ms
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)
4ms
Safety of MB-CART2019.1 in Lymphoma Patients (MB-CART2019.1 Lymphoma / DALY 1) (clinicaltrials.gov)
P1/2, N=12, Completed, Miltenyi Biomedicine GmbH | Active, not recruiting --> Completed | Trial completion date: Dec 2025 --> May 2024
Trial completion • Trial completion date
|
BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
|
zamtocabtagene autoleucel (MB-CART2019.1)
4ms
New trial • Gene therapy
|
MB-CART 19.1 • MB-CART20.1 • zamtocabtagene autoleucel (MB-CART2019.1)
4ms
New P2 trial
|
zamtocabtagene autoleucel (MB-CART2019.1)
9ms
DALY 2-EU: Efficacy and Safety of MB-CART2019.1 vs. SoC in Lymphoma Patients (clinicaltrials.gov)
P2, N=168, Recruiting, Miltenyi Biomedicine GmbH | Trial completion date: Dec 2024 --> Jul 2027 | Trial primary completion date: Dec 2023 --> Dec 2024
Trial completion date • Trial primary 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)
over1year
DALY II USA: DALY 2.0 USA/ MB-CART2019.1 for DLBCL (clinicaltrials.gov)
P2, N=110, Recruiting, Miltenyi Biomedicine GmbH | N=65 --> 110 | Trial completion date: Jun 2025 --> Dec 2026 | Trial primary completion date: Jul 2023 --> Dec 2024
Enrollment change • Trial completion date • Trial primary completion date
|
CD20 (Membrane Spanning 4-Domains A1)
|
CD19 expression
|
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, Recruiting, Miltenyi Biomedicine GmbH | Trial completion date: Sep 2024 --> Dec 2024 | Trial primary completion date: Sep 2023 --> Dec 2023
Trial completion date • Trial primary 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)
almost2years
CAR T-Cell Therapy
|
CD19 (CD19 Molecule)
|
zamtocabtagene autoleucel (MB-CART2019.1)
almost2years
DALY II USA: DALY 2.0 USA/ MB-CART2019.1 for DLBCL (clinicaltrials.gov)
P2, N=65, Recruiting, Miltenyi Biomedicine GmbH | Trial completion date: Sep 2024 --> Jun 2025 | Trial primary completion date: Oct 2022 --> Jul 2023
Trial completion date • Trial primary completion date
|
CD20 (Membrane Spanning 4-Domains A1) • CD19 (CD19 Molecule)
|
CD19 expression
|
zamtocabtagene autoleucel (MB-CART2019.1)
almost2years
Trial in Progress: A Randomized Phase II Study of MB-CART2019.1 Compared to Standard of Care Therapy in Patients with Relapsed/Refractory DLBCL Ineligible for High-Dose Chemotherapy and Autologous Stem Cell Transplantation - DALY 2-EU Trial (ASH 2022)
MB-CART2019.1 is manufactured without freeze-thaw cycles and intended to be infused as a fresh product (day 0) after lymphodepleting chemotherapy with fludarabine 30 mg/m2body surface area (BSA)/d and cyclophosphamide 300 mg/m2 BSA/d on day -5 to day -3 prior to MB-CART2019.1 infusion. The comparator treatment consists of R-GemOx (rituximab, gemcitabine and oxaliplatin) or Pola-BR (polatuzumab vedotin, bendamustine and rituximab), pre-defined to a maximum of 10% of enrolled patients...Safety endpoints include frequency and severity of adverse events as well as the use of tocilizumab and/or high-dose steroids...The study is actively enrolling patients since August 2021. In addition, MB-CART2019.1 is under development in the United States, and a separate pivotal Phase II trial is currently enrolling patients with r/r DLBCL who have failed at least two lines of prior systemic therapy (DALY 2.0 USA, NCT04792489).
Clinical • P2 data
|
CD19 (CD19 Molecule) • CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
|
gemcitabine • Rituxan (rituximab) • cyclophosphamide • oxaliplatin • bendamustine • fludarabine IV • Actemra IV (tocilizumab) • Polivy (polatuzumab vedotin-piiq) • zamtocabtagene autoleucel (MB-CART2019.1)
2years
Characterization and T-Cell Repertoire of MB-CART2019.1 (Zamtocabtagene autoleucel) - Data from the Phase I Trial in Patients with Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (ASH 2022)
All 12 MB-CART2019.1 DPs exhibited a consistent and reproducible expansion profile, high CD4:CD8 ratio, high TCM proportion and low expression of exhaustion markers. Increased proliferative ability in the DP, higher Cmax, as well as maintaining higher levels of TCM during in vivo expansion were characteristically elevated parameters of pts with CR. Other product characteristics, e.g. CD4:CD8 ratio or number of infused T-cells, were not significantly associated with in vivo performance.
Clinical • P1 data • PD(L)-1 Biomarker • IO biomarker
|
CD19 (CD19 Molecule) • CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • LAG3 (Lymphocyte Activating 3) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2) • IL2RA (Interleukin 2 receptor, alpha) • IL7R (Interleukin 7 Receptor) • TNFRSF9 (TNF Receptor Superfamily Member 9) • CD27 (CD27 Molecule) • CD40LG (CD40 ligand) • IL15 (Interleukin 15) • IL7 (Interleukin 7)
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LAG3 expression • IL7R expression
|
zamtocabtagene autoleucel (MB-CART2019.1)
over2years
DALY 2.0 USA/ MB-CART2019.1 for DLBCL (clinicaltrials.gov)
P2, N=65, Recruiting, Miltenyi Biomedicine GmbH | Trial completion date: Apr 2024 --> Sep 2024 | Trial primary completion date: May 2022 --> Oct 2022
Trial completion date • Trial primary completion date
|
CD20 (Membrane Spanning 4-Domains A1) • CD19 (CD19 Molecule)
|
CD19 expression
|
zamtocabtagene autoleucel (MB-CART2019.1)
over2years
PHASE I TRIAL OF MB-CART2019.1 IN PATIENTES WITH RELAPSED OR REFRATORY B-CELL NON-HODGKIN LYMPHOMA: 2 YEAR FOLLOW-UP REPORT (EHA 2022)
Fludarabine and cyclophosphamide were used for lymphodepletion. Importantly, all 5 pts with CR were still in CR 12 months after treatment and have now completed the 2-year follow-up visit without evidence of relapse. MB-CART2019.1 is currently challenging conventional immune-chemotherapy in a randomized Phase II trial for elderly, non-transplant eligible pts with first progression or relapse of aggressive B-NHL ( NCT04844866).
Clinical • P1 data
|
CD19 (CD19 Molecule) • CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
|
CD20 positive • CD19 positive
|
cyclophosphamide • fludarabine IV • zamtocabtagene autoleucel (MB-CART2019.1)
over2years
TRIAL IN PROGRESS: A RANDOMIZED PHASE II STUDY OF MB-CART2019.1 COMPARED TO STANDARD OF CARE THERAPY IN PATIENTS WITH RELAPSED/REFRACTORY DLBCL INELIGIBLE FOR AUTOLOGOUS STEM CELL TRANSPLANTATION (EHA 2022)
Safety endpoints include frequency and severity of adverse events as well as the use of tocilizumab and/or high-dose steroids...MB-CART2019.1 is infused as a fresh product (day 0) after a lymphodepleting chemotherapy regimen consisting of fludarabine 30 mg/m 2 body surface area (BSA) and cyclophosphamide 300mg/m 2 BSA (each from day -5 to day -3 prior to MB-CART2019.1 infusion). The comparator treatment consists of either R-GemOx (rituximab, gemcitabine and oxaliplatin) or BR (rituximab and bendamustine) plus polatuzumab vedotin, pre-defined to a maximum of 10% of enrolled patients...The study is actively enrolling patients since August 2021. Clinical trial information: NCT04844866.
Clinical • P2 data
|
CD19 (CD19 Molecule) • CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
|
gemcitabine • Rituxan (rituximab) • cyclophosphamide • oxaliplatin • bendamustine • fludarabine IV • Actemra IV (tocilizumab) • Polivy (polatuzumab vedotin-piiq) • zamtocabtagene autoleucel (MB-CART2019.1)
3years
DALY 2-EU: Efficacy and Safety of MB-CART2019.1 vs. SoC in Lymphoma Patients (clinicaltrials.gov)
P2, N=168, Recruiting, Miltenyi Biomedicine GmbH | Not yet recruiting --> Recruiting | Trial completion date: Jun 2024 --> Sep 2024 | Initiation date: Apr 2021 --> Aug 2021 | Trial primary completion date: Jun 2023 --> Sep 2023
Clinical • Enrollment open • Trial completion date • Trial initiation date • Trial primary 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)
over3years
MB-CART2019.1 Lymphoma (clinicaltrials.gov)
P1/2, N=12, Active, not recruiting, Miltenyi Biomedicine GmbH | Trial completion date: Jul 2025 --> Dec 2025
Clinical • Trial completion date
|
BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
|
CD19 expression • BCL6 rearrangement • BCL2 rearrangement
|
zamtocabtagene autoleucel (MB-CART2019.1)
over3years
New P2 trial
|
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)
4years
[VIRTUAL] Phase I Trial of MB-CART2019.1, a Novel CD20 and CD19 Targeting Tandem Chimeric Antigen Receptor, in Patients with Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (ASH 2020)
Fludarabine/cyclophosphamide lymphodepleting chemotherapy was administered from day -5 to -3...Tocilizumab was given in 1 patient...The sustained expansion of tandem CAR T-cells was accompanied by efficacy: all patients (6/6) treated on DL2 responded and all 5 patients with CR (5/5) are in ongoing remission by the time of this report. Based on the promising risk-to-benefit ratio observed in our study, evaluation of MB-CART2019.1 at a dose of 2.5x106/kg body weight in clinical phase II and phase III trials for patients with relapsed aggressive B-NHL is underway.
Clinical • P1 data
|
CD20 (Membrane Spanning 4-Domains A1) • CD19 (CD19 Molecule)
|
CD20 positive • CD19 positive
|
fludarabine IV • Actemra IV (tocilizumab) • zamtocabtagene autoleucel (MB-CART2019.1)
4years
[VIRTUAL] Phase I study of MB-CART2019.1, a novel CD20 and CD19 tandem chimeric antigen receptor, in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (DGHO 2020)
In this first-in-human dose finding study of MB-CART2019.1 no DLT occurred. Furthermore, no severe CRS or neurotoxicity and no grade 5 AE were observed. General feasibility and safety were very good in this cohort of elderly r/r B-NHL patients.
Clinical • P1 data
|
CD20 (Membrane Spanning 4-Domains A1) • CD19 (CD19 Molecule)
|
zamtocabtagene autoleucel (MB-CART2019.1)
4years
[VIRTUAL] Phase I study of MB-CART2019.1, a novel CD20 and CD19 tandem chimeric antigen receptor, in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (DGHO 2020)
In this first-in-human dose finding study of MB-CART2019.1 no DLT occurred. Furthermore, no severe CRS or neurotoxicity and no grade 5 AE were observed. General feasibility and safety were very good in this cohort of elderly r/r B-NHL patients.
Clinical • P1 data
|
CD20 (Membrane Spanning 4-Domains A1) • CD19 (CD19 Molecule)
|
zamtocabtagene autoleucel (MB-CART2019.1)
4years
[VIRTUAL] Phase I study of MB-CART2019.1, a novel CD20 and CD19 tandem chimeric antigen receptor, in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (DGHO 2020)
In this first-in-human dose finding study of MB-CART2019.1 no DLT occurred. Furthermore, no severe CRS or neurotoxicity and no grade 5 AE were observed. General feasibility and safety were very good in this cohort of elderly r/r B-NHL patients.
Clinical • P1 data
|
CD20 (Membrane Spanning 4-Domains A1) • CD19 (CD19 Molecule)
|
zamtocabtagene autoleucel (MB-CART2019.1)
4years
[VIRTUAL] Phase I study of MB-CART2019.1, a novel CD20 and CD19 tandem chimeric antigen receptor, in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (DGHO 2020)
In this first-in-human dose finding study of MB-CART2019.1 no DLT occurred. Furthermore, no severe CRS or neurotoxicity and no grade 5 AE were observed. General feasibility and safety were very good in this cohort of elderly r/r B-NHL patients.
Clinical • P1 data
|
CD20 (Membrane Spanning 4-Domains A1) • CD19 (CD19 Molecule)
|
zamtocabtagene autoleucel (MB-CART2019.1)
almost5years
MB-CART2019.1 Lymphoma (clinicaltrials.gov)
P1/2, N=12, Active, not recruiting, Miltenyi Biotec B.V. & Co. KG | Trial completion date: Mar 2025 --> Jul 2025 | Trial primary completion date: Sep 2019 --> Dec 2020 | Recruiting --> Active, not recruiting
Clinical • Enrollment closed • Trial completion date • Trial primary completion date
|
BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
|
CD19 expression • BCL6 rearrangement • BCL2 rearrangement
|
zamtocabtagene autoleucel (MB-CART2019.1)