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DRUG:

MB-106

i
Other names: MB106, MB-106, MB-106 CD20 CAR, MB 106
Company:
Fortress, Fred Hutchinson Cancer Center
Drug class:
CD20-targeted CAR-T immunotherapy
4ms
MB106-CD20-001: Study to Assess Safety, Tolerability and Efficacy of MB-106 in Patients With Relapsed or Refractory B-Cell NHL or CLL (clinicaltrials.gov)
P1/2, N=20, Terminated, Mustang Bio | N=287 --> 20 | Trial completion date: Sep 2026 --> Apr 2024 | Recruiting --> Terminated | Trial primary completion date: Sep 2026 --> Apr 2024; Business reasons
Enrollment change • Trial completion date • Trial termination • Trial primary completion date
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BCL2 (B-cell CLL/lymphoma 2) • CD20 (Membrane Spanning 4-Domains A1) • BCL6 (B-cell CLL/lymphoma 6)
|
MB-106
4ms
Long-term Follow-up Study in Patients Previously Treated With a Mustang Bio CAR-T Cell Investigational Product. (clinicaltrials.gov)
P=N/A, N=3, Terminated, Mustang Bio | N=331 --> 3 | Trial completion date: Jul 2041 --> Apr 2024 | Enrolling by invitation --> Terminated | Trial primary completion date: Apr 2041 --> Apr 2024; Business Reasons
Enrollment change • Trial completion date • Trial termination • Trial primary completion date • CAR T-Cell Therapy
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MB-106 • MB-102
5ms
Enrollment closed • Trial primary completion date
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BCL2 (B-cell CLL/lymphoma 2)
|
cyclophosphamide • fludarabine IV • MB-106
1year
Efficacy and Safety of a Third Generation CD20 CAR-T (MB-106) for Treatment of Relapsed/Refractory Indolent B-Cell Non-Hodgkin Lymphoma: Phase-1 Results from a Multicenter Trial (ASH 2023)
Following lymphodepletion (cyclophosphamide 300 mg/m2/day and fludarabine 30 mg/m2/day for 3 days), MB-106 is administered to patients with indolent B-cell NHL at one of two dose levels (DL): DL1, 3.3×106; and DL2, 1.0×107 cells/kg. Treatment with MB-106, a third generation CD20 targeting CAR-T, resulted in responses, including CRs, and CAR-T persistence in patients with R/R indolent NHL and was associated with favorable safety profile with no occurrence of Grade 3 or Grade 4 cytokine release syndrome and no ICANS of any grade. CRs have been observed in patients previously treated with CD19-targeted CAR-T in both this multicenter trial and the original single institution trial. Dosing is ongoing in the final dosing level (1.0×107 cells/kg) to establish the recommended Phase 2 dose for a planned pivotal trial in WM.
Clinical • P1 data • IO biomarker
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CD20 (Membrane Spanning 4-Domains A1)
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CD20 expression
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cyclophosphamide • fludarabine IV • MB-106
over1year
CD20 CAR-T THERAPY WITH MB-106 FOR BTK INHIBITOR-REFRACTORY WALDENSTRÖM MACROGLOBULINEMIA (WM)/ LYMPHOPLASMACYTIC LYMPHOMA (LPL) – SINGLE INSTITUTION STUDY (EHA 2023)
Lymphodepletion (LD) consists of cyclophosphamide + fludarabine...All 4 pts had BTKi refractory disease (2 ibrutinib, 1 acalabrutinib, 1 zanubrutinib)...One pt received bridging therapy with bendamustine after leukapheresis and before CAR-T infusion (3 DL3 and 1 DL2)... Early results of CD20 CAR-T therapy with MB-106 for BTKi-refractory WM/LPL suggest high efficacy and favorablesafety profile with no grade 3/4 CRS and no grade 2/3/4 ICANS. MB-106 has received orphan drug designation by the US FDA for WM, and a multicenter study is currently active in the US for WM and other B-NHLs. Enrollment also continues in this single institution study, and the results will be updated during the presentation.
Clinical • IO biomarker
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MYD88 (MYD88 Innate Immune Signal Transduction Adaptor) • CXCR4 (Chemokine (C-X-C motif) receptor 4) • B2M (Beta-2-microglobulin)
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MYD88 mutation • MYD88 L265P • CD20 expression
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Imbruvica (ibrutinib) • cyclophosphamide • Brukinsa (zanubrutinib) • Calquence (acalabrutinib) • bendamustine • fludarabine IV • MB-106
over1year
HIGH EFFICACY AND FAVORABLE SAFETY OF 3RD GENERATION CD20 CAR-T (MB-106) FOR OUTPATIENT TREATMENT OF FOLLICULAR LYMPHOMA (FL)—RESULTS OF A SINGLE-INSTITUTION TRIAL (ICML 2023)
Treatment with MB-106, a 3rd-generation CD20 targeting CAR-T, resulted in high ORR and CR rates and CAR-T persistence in FL pts and was associated with a favorable safety profile with no occurrence of Gr 3 or Gr 4 CRS and no ICANS of any grade. A multicenter trial for treatment of B-cell malignancies including FL is ongoing in the US.
Clinical
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CD20 (Membrane Spanning 4-Domains A1)
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CD20 positive
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MB-106
over1year
Enrollment change
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BCL2 (B-cell CLL/lymphoma 2)
|
CD20 expression
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cyclophosphamide • fludarabine IV • MB-106
over2years
Enrollment open
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BCL2 (B-cell CLL/lymphoma 2) • CD20 (Membrane Spanning 4-Domains A1) • CD19 (CD19 Molecule) • BCL6 (B-cell CLL/lymphoma 6)
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CD19 positive • CD20 expression • BCL6 rearrangement • BCL2 rearrangement
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MB-106
over2years
EFFICACY AND SAFETY OF A THIRD GENERATION CD20 CART (MB-106) FOR TREATMENT OF RELAPSED/REFRACTORY FOLLICULAR LYMPHOMA (FL) (EHA 2022)
Chimeric antigen receptor T-cells (CAR-T) targeting CD19 are effective, and axicabtagene ciloleucel is currently approved by FDA for treatment of patients (pts) with relapsed FL, but toxicities like cytokine-release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) may limit its use...Lymphodepletion (LD) consists of cyclophosphamide (Cy) ± fludarabine (Flu)...Median time between leukapheresis and LD was 15 days (range: 9-21) and 2 pts received bridging therapy with lenalidomide (1) and high-dose corticosteroids (1)...Conclusion Treatment with MB-106, a third generation CD20 targeting CAR-T, resulted in high ORR and CR rates and CAR-T persistence in FL pts and was associated with favorable safety profile with no occurrence of Gr 3 or Gr 4 CRS and no ICANS event of any grade. A multicenter trial for treatment of B-cell malignancies including FL will start enrollment in 2022.
Clinical • IO biomarker
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CD20 (Membrane Spanning 4-Domains A1) • CD19 (CD19 Molecule)
|
CD20 expression
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lenalidomide • cyclophosphamide • Yescarta (axicabtagene ciloleucel) • fludarabine IV • MB-106
over2years
New P1/2 trial
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BCL2 (B-cell CLL/lymphoma 2) • CD20 (Membrane Spanning 4-Domains A1) • CD19 (CD19 Molecule) • BCL6 (B-cell CLL/lymphoma 6)
|
CD19 positive • CD20 expression • BCL6 rearrangement • BCL2 rearrangement
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MB-106
over3years
[VIRTUAL] IMMUNOTHERAPY USING A 3RD GENERATION CD20 TARGETED CAR T-CELL (MB-106) FOR TREATMENT OF B-CELL NON-HODGKIN LYMPHOMA (B-NHL) AND CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) (EHA 2021)
Lymphodepletion (LD) consists of cyclophosphamide (Cy) ± fludarabine (Flu)...Only 1 pt required tocilizumab and dexamethasone...Treatment with MB-106 has also resulted in high ORR and CR rates with ongoing remissions in all patients who achieved a CR. Enrollment is currently ongoing and the data will be updated at the time of presentation.
CAR T-Cell Therapy
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CD20 (Membrane Spanning 4-Domains A1) • CD19 (CD19 Molecule)
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dexamethasone • fludarabine IV • Actemra IV (tocilizumab) • MB-106
4years
[VIRTUAL] Third Generation CD20 Targeted CAR T-Cell Therapy (MB-106) for Treatment of Patients with Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (ASH 2020)
Lymphodepletion (LD) consists of cyclophosphamide (Cy) ± fludarabine (Flu)... Early results of our ongoing study of CD20 CAR-T for high-risk NHLs suggests an extremely favorable safety profile (no CRS or ICANS of any grades) with the modified manufacturing process. There is also evidence of clinical activity even at low dose levels with observed CRs at DLs 1 and 2. Enrollment at higher DLs is currently ongoing and the data will be updated at the time of presentation.
Clinical • CAR T-Cell Therapy
|
CD20 (Membrane Spanning 4-Domains A1) • CD19 (CD19 Molecule) • CD8 (cluster of differentiation 8)
|
fludarabine IV • MB-106 • cyclophosphamide intravenous
5years
CD20 Targeted CAR-T for High-Risk B-Cell Non-Hodgkin Lymphomas (ASH 2019)
Background: Chimeric antigen receptor T-cells (CAR-T) targeting CD19 have shown clinical efficacy in high-risk B-cell lymphomas, which has led to approval of 2 such therapies (axicabtagene ciloleucel and tisagenlecleucel) for large B-cell lymphoma after 2 lines of treatment... MB-106 is a fully human third-generation CD20 targeted CAR-T with both 4-1BB and CD28 costimulatory domains...Lymphodepletion (LD) chemotherapy consists of fludarabine and cyclophosphamide...Patients need to meet standard organ function criteria and have adequate blood counts (ANC >750, Hb >8.5, Plts >50,000). Patients with significant neurologic conditions, active CNS lymphoma, or need for systemic immunosuppressive therapy are excluded from the study.
IO biomarker
|
CD8 (cluster of differentiation 8)
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Yescarta (axicabtagene ciloleucel) • Kymriah (tisagenlecleucel-T) • fludarabine IV • MB-106