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    1year
    Updated Results from a Phase I Dose Escalation Study of the Rapidly-Switchable Universal CAR-T Therapy UniCAR-T-CD123 in Relapsed/Refractory AML (ASH 2023)
    Repeated dosing of TM in consolidation cycles resulted in robust re-expansion of UniCAR-T with deeper remissions of extended durability. The switchable mechanism provides proven rapid reversal of safety events, enabling higher dose levels.
    P1 data • IO biomarker
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    NPM1 (Nucleophosmin 1) • CD123 (Interleukin 3 Receptor Subunit Alpha) • IL3RA (Interleukin 3 Receptor Subunit Alpha)
    |
    NPM1 mutation • CD123 expression • IL3RA expression
    |
    AVC-101
    over1year
    Dose-escalating Trial With UniCAR02-T Cells and CD123 Target Module (TM123) in Patients With Hematologic and Lymphatic Malignancies (clinicaltrials.gov)
    P1, N=90, Recruiting, AvenCell Europe GmbH | N=45 --> 90 | Trial completion date: Jun 2023 --> Sep 2025 | Trial primary completion date: Dec 2022 --> May 2025
    Enrollment change • Trial completion date • Trial primary completion date • Combination therapy
    |
    IL3RA (Interleukin 3 Receptor Subunit Alpha)
    |
    CD123 positive
    |
    cyclophosphamide • fludarabine IV • AVC-101
    2years
    Phase 1 Dose Escalation Study of the Rapidly Switchable Universal CAR-T Therapy Unicar-T-CD123 in Relapsed/Refractory AML (ASH 2022)
    Standard fludarabine/cyclophosphamide lymphodepletion was given on day -5 to -3 prior to treatment start. No clear correlation was observed between treatment effect or toxicity and cell or TM dose, respectively. The observed effects warrant further investigation and an expansion cohort will be implemented at dose level 16.
    P1 data • IO biomarker
    |
    CD123 (Interleukin 3 Receptor Subunit Alpha)
    |
    CD123 expression
    |
    cyclophosphamide • fludarabine IV • AVC-101
    over3years
    [VIRTUAL] Expansion kinetics and cytokine profiles of UniCAR-T-CD123, a rapidly switchable two-component CAR-T therapy, in patients with relapsed/refractory AML (AACR 2021)
    The initial clinical and translational results of UniCAR-T-CD123 represent, to our understanding, a first time evidence for a well-tolerated and effective rapidly switchable CAR-T product. Even though the number of patients treated so far is limited, the data obtained provide clinical proof-of-concept for the opportunity to abrogate side effects by withdrawal of TM123. Enrollment into the Phase IA study is ongoing.
    Clinical • IO biomarker
    |
    IFNG (Interferon, gamma) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • CD123 (Interleukin 3 Receptor Subunit Alpha) • IL2 (Interleukin 2) • CSF2 (Colony stimulating factor 2)
    |
    AVC-101
    over3years
    Proof-of-concept for Rapidly Switchable Universal CAR-T Platform with UniCAR-T-CD123 in Relapsed/Refractory AML. (PubMed, Blood)
    No abstract available
    Journal
    |
    CD123 (Interleukin 3 Receptor Subunit Alpha)
    |
    AVC-101
    over4years
    [VIRTUAL] More than a bridging therapy: Targeting CD123 with rapidly switchable universal CAR-T cells for treatment of acute leukemia (AACR-II 2020)
    In summary, in vitro and in vivo evidence suggests that UniCAR-T-CD123 could provide strong efficacy against CD123 expressing hematological malignancies while providing excellent control and ensuring recovery of normal hematopoiesis post treatment. A phase IA dose-finding study is ongoing.
    CAR T-Cell Therapy
    |
    CD123 (Interleukin 3 Receptor Subunit Alpha)
    |
    AVC-101