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    DRUG:

    Aucatzyl (obecabtagene autoleucel)

    i
    Other names: AUTO1, CD19CAT-41BBZ CAR T-cells, AUTO 1, CD19 CAR T-cells, obe-cel, CAT19
    Company:
    Autolus
    Drug class:
    CD19-targeted CAR-T immunotherapy
    Related drugs:
    2d
    CARLYSE: Obe-cel in Adolescent [Applicable in UK Only] and Adult Severe, Refractory Systemic Lupus Erythematosus (clinicaltrials.gov)
    P1, N=18, Recruiting, Autolus Limited | N=12 --> 18
    Enrollment change
    |
    cyclophosphamide • fludarabine IV • Aucatzyl (obecabtagene autoleucel)
    2ms
    ALLCAR19: Immunotherapy for High Risk/Relapsed CD19+ Acute Lymphoblastic Leukaemia, B-cell Non-Hodgkin's Lymphoma (B-NHL) and Chronic Lymphocytic Leukaemia (CLL)/ Small Lymphocytic Lymphoma (SLL) Using CAR T-cells to Target CD19 (clinicaltrials.gov)
    P1, N=72, Active, not recruiting, University College, London | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Aucatzyl (obecabtagene autoleucel)
    3ms
    Phase 2 Study Assessing the Clinical Activity and Safety of Obecabtagene Autoleucel as a Consolidation in Patients With Newly Diagnosed High-risk B-cell Acute Lymphocytic Leukemia (ALL) (clinicaltrials.gov)
    P2, N=30, Recruiting, M.D. Anderson Cancer Center | Not yet recruiting --> Recruiting | Initiation date: Dec 2025 --> Aug 2025
    Enrollment open • Trial initiation date
    |
    Aucatzyl (obecabtagene autoleucel)
    3ms
    FELIX: A Study of CD19 Targeted CAR T Cell Therapy in Adult Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukaemia (ALL) (clinicaltrials.gov)
    P1/2, N=153, Active, not recruiting, Autolus Limited | Trial completion date: May 2025 --> Jun 2029 | Trial primary completion date: May 2025 --> Jun 2029
    Trial completion date • Trial primary completion date
    |
    CD19 positive
    |
    clonoSEQ
    |
    cyclophosphamide • fludarabine IV • Aucatzyl (obecabtagene autoleucel)
    3ms
    BOBCAT: Obe-cel in Refractory Progressive Forms of Multiple Sclerosis (clinicaltrials.gov)
    P1, N=18, Recruiting, Autolus Limited
    New P1 trial
    |
    Aucatzyl (obecabtagene autoleucel)
    5ms
    Obe-cel in Severe, Refractory Systemic Lupus Erythematosus With Active Lupus Nephritis (clinicaltrials.gov)
    P2, N=35, Not yet recruiting, Autolus Limited
    New P2 trial
    |
    Aucatzyl (obecabtagene autoleucel)
    5ms
    Phase 2 Study Assessing the Clinical Activity and Safety of Obecabtagene Autoleucel as a Consolidation in Patients With Newly Diagnosed High-risk B-cell Acute Lymphocytic Leukemia (ALL) (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, M.D. Anderson Cancer Center
    New P2 trial
    |
    Aucatzyl (obecabtagene autoleucel)
    7ms
    CARLYSE: A Study of CD19 Targeted CAR T Cell Therapy in Patients With Severe, Refractory Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov)
    P1, N=12, Recruiting, Autolus Limited | Trial completion date: Oct 2025 --> Dec 2026 | Trial primary completion date: Nov 2024 --> Dec 2025
    Trial completion date • Trial primary completion date
    |
    cyclophosphamide • fludarabine IV • Aucatzyl (obecabtagene autoleucel)
    10ms
    Expanded Access Program for OOS Obe-cel (clinicaltrials.gov)
    P=N/A, N=0, Available, Autolus Limited
    New trial
    |
    Aucatzyl (obecabtagene autoleucel)
    1year
    Obecabtagene autoleucel (obe-cel) for Adult Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia (R/R B-ALL): Deep Molecular Remission May Predict Better Outcomes (ASH 2024)
    Conclusions : Eighty-four percent of responders to obe-cel for whom MRD by NGS could be analyzed achieved MRD <10‾6 leukemic cells which was associated with more durable responses, and higher EFS and OS rates than those observed in pts with MRD ≥10‾4 and between 10‾4 and 10‾6 leukemic cells. Pts who did not achieve MRD <10‾6 had poorer outcomes.
    Clinical
    |
    clonoSEQ
    |
    Aucatzyl (obecabtagene autoleucel)
    over1year
    CARLYSE: A Study of CD19 Targeted CAR T Cell Therapy in Patients With Severe, Refractory Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov)
    P1, N=12, Recruiting, Autolus Limited
    New P1 trial • CAR T-Cell Therapy
    |
    cyclophosphamide • Aucatzyl (obecabtagene autoleucel)
    almost2years
    A Study of CD19 Targeted CAR T Cell Therapy in Pediatric Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukaemia (B ALL) and Aggressive Mature B-cell Non-Hodgkin Lymphoma (B NHL) (clinicaltrials.gov)
    P1, N=24, Recruiting, Autolus Limited
    New P1 trial
    |
    cyclophosphamide • Aucatzyl (obecabtagene autoleucel)