obecabtagene autoleucel (AUTO1) / Autolus 
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  • ||||||||||  obecabtagene autoleucel (AUTO1) / Autolus
    Long-Term Follow-up of AUTO1, a Fast-Off Rate CD19 CAR, in Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia and Factors Associated with Durable Response. () -  Dec 16, 2022 - Abstract #TCTASTCTCIBMTR2023TCT_ASTCT_CIBMTR_906;    
    P1
    METHODS Subjects ≥ 16y received fludarabine (30mg/m 2 x3) and cyclophosphamide (60mg/kg x1) followed by split dose AUTO1 (day 0: ≥20% Bone Marrow (BM) blasts, AUTO1 dose=10 x10 6 ; <20% BM blasts, AUTO1 dose=100 x10 6...RESULTS 20 adult B-ALL patients (median age, 41.5y), previously treated with blinatumomab (25%), inotuzumab ozogamicin (50%) and allogeneic stem cell transplantation (65%), were infused with AUTO1...This suggests that CAR-T persistence and B cell aplasia (denoting functional persistence) are associated with long-term clinical responses. We will present further analysis of factors associated with response and relapse at the conference.
  • ||||||||||  obecabtagene autoleucel (AUTO1) / Autolus, AUTO3 / Autolus
    DUAL ANTIGEN TARGETING WITH CO-TRANSDUCED CD19/22 CAR T CELLS FOR RELAPSED/REFRACTORY ALL (Hall Strauss 1-2) -  May 13, 2022 - Abstract #EHA2022EHA_2708;    
    P1
    Following fludarabine/cyclophosphamide lymphodepletion, patients received 1x10 6 /kg CAR + T cells...Five of 8 patients had relapsed post allogeneic SCT, 4 had received prior Blinatumomab/Inotuzumab and 3 had relapsed after prior Tisagenlecleucel...CAR T cell products had a central memory phenotype with predominance of CD19/22 double positive cells (median 59.3%) and balanced populations of CD19 and CD22 single positive cells (16% and 10.9% respectively).Cytokine release syndrome (CRS) occurred in 7/8 patients (grade 1 n=2 , grade 2 n=5 ) requiring Tocilizumab in 3 cases, but severe (≥ grade 3) CRS was not seen and no patients required ICU admission for CRS...Conclusion We demonstrate that dual CD19/22 targeting CAR T cells generated by co-transduction show an acceptable safety profile, with robust expansion/persistence and early efficacy in a heavily pre-treated cohort. To date with limited follow-up we have not observed antigen negative relapse but longer follow up is needed.
  • ||||||||||  obecabtagene autoleucel (AUTO1) / Autolus
    SAFETY AND EFFICACY FINDINGS OF AUTO1, A FAST-OFF RATE CD19 CAR, IN RELAPSED/REFRACTORY PRIMARY CNS LYMPHOMA () -  May 13, 2022 - Abstract #EHA2022EHA_1414;    
    P1
    Study Design: Subjects>/=16y underwent lymphodepletion with fludarabine (Flu;30mg/m2x3) and cyclophosphamide (Cy;60mg/kgx1) and Pembrolizumab (200mgx1) prior to IV AUTO1 infusion (250x10^6 CAR-T)...I-VEN administration was well-tolerated and AUTO1 demonstrated activity via direct CSF infusion in a patient who failed IV therapy. Additional patients, updated biological data and longer follow-up will be presented.
  • ||||||||||  obecabtagene autoleucel (AUTO1) / Autolus
    Industrialization of an Academic Miltenyi Prodigy-Based CAR T Process (Salt Palace Convention Center Hall A) -  Jan 9, 2022 - Abstract #TCTASTCTCIBMTR2022TCT_ASTCT_CIBMTR_980;    
    P1, P1/2
    Clinical testing in two academic studies in r/r paediatric [NCT02443831; CARPALL] and adult B-ALL, B-NHL and B-CLL [NCT02935257; ALLCAR19] confirmed the intended function of the receptor, with low levels of cytokine release syndrome (CRS) and neurotoxicity and long-term engraftment of CAR T-cells 1,2...CONCLUSION Industrialization of an autologous Miltenyi CAR T process is feasible, leading to a comparable product to that manufactured in an academic setting. We have now opened the pivotal multi-centre phase II part of the FELIX study in r/r adult B-ALL patients.
  • ||||||||||  obecabtagene autoleucel (AUTO1) / Autolus
    Safety and Efficacy of AUTO1, a Fast-Off Rate CD19 CAR in Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (B-NHL) and Chronic Lymphocytic Leukaemia (CLL) (GWCC - Hall B5, Level 1) -  Nov 5, 2021 - Abstract #ASH2021ASH_5521;    
    P1
    Study design: Subjects ≥ 16y underwent lymphodepletion with fludarabine (30mg/m 2 x3) and cyclophosphamide (60mg/kg x1) prior to AUTO1 infusion, with the exception of the DLBCL cohort who additionally received a single dose of pembrolizumab (200mg) on day -1 to potentiate CAR-T expansion...1/9 developed MAS which resolved with anakinra/dexamethasone...Early data shows 100% complete remission rates and excellent CAR engraftment/expansion. Additional MCL, CLL and DLBCL patients, updated data and longer follow up will be presented.
  • ||||||||||  obecabtagene autoleucel (AUTO1) / Autolus
    Industrialization of an Academic Miltenyi Prodigy-Based CAR T Process (GWCC - Hall A1) -  Nov 5, 2021 - Abstract #ASH2021ASH_1887;    
    P1, P1/2
    Clinical testing in two academic studies in relapsed/refractory (r/r) paediatric [ NCT02443831; CARPALL ] and adult B-ALL, B-NHL and B-CLL [NCT02935257; ALLCAR19] confirmed the intended function of the receptor, with low levels of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) and long-term engraftment of CAR T-cells 1,2...CONCLUSION Industrialization of an autologous Miltenyi CAR T process is feasible, leading to a comparable product to that manufactured in an academic setting. We have now opened the pivotal multi-center phase II part of the FELIX study in r/r adult B-ALL patients.