^
    6ms
    IOV-CLL-01: Study of Autologous Peripheral Blood Lymphocytes in the Treatment of Patients With CLL or SLL (clinicaltrials.gov)
    P1/2, N=70, Active, not recruiting, Iovance Biotherapeutics, Inc. | Recruiting --> Active, not recruiting | Trial completion date: Jul 2024 --> Sep 2025 | Trial primary completion date: Apr 2024 --> Sep 2025
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    TP53 (Tumor protein P53) • IL2 (Interleukin 2)
    |
    TP53 mutation • TP53 mutation + Chr del(17p)
    |
    IOV-2001
    over1year
    IOV-CLL-01: Study of Autologous Peripheral Blood Lymphocytes in the Treatment of Patients With CLL or SLL (clinicaltrials.gov)
    P1/2, N=70, Recruiting, Iovance Biotherapeutics, Inc. | Trial completion date: Jan 2023 --> Jul 2024 | Trial primary completion date: Oct 2022 --> Apr 2024
    Trial completion date • Trial primary completion date
    |
    TP53 (Tumor protein P53) • IL2 (Interleukin 2)
    |
    TP53 mutation • TP53 mutation + Chr del(17p)
    |
    IOV-2001
    3years
    Trial in Progress: Phase 1/2 Study Evaluating the Safety and Efficacy of Iov-2001, an Autologous, Non-Genetically Modified, Polyclonal T-Cell Product, in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) (ASH 2021)
    Background Bruton tyrosine kinase (BTK) inhibitors (ie, ibrutinib, acalabrutinib) are approved for treating patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), and can mediate durable responses in some patients; however, relapses are common, primarily due to acquired mutations in BTK enzyme and/or phospholipase C gamma 2 (Albitar F, et al...Treatment consists of a preparative regimen of lymphodepleting chemotherapy (cyclophosphamide IV 500 mg/m 2 and fludarabine IV 30 mg/m 2 ) for 3 days, followed by 2 days of rest, a single infusion of IOV-2001, and 6 doses of either low-dose (9 MIU SC) or high-dose (600,000 IU/kg IV) interleukin-2 (IL-2; Figure 1)...Patients ages ≥18 years, diagnosed with CLL/SLL with radiographically measurable disease, Eastern Cooperative Oncology Group performance status of 0–1, and meeting prior therapy criteria according to Table 2 are eligible for inclusion. Four US sites are currently active and enrolling patients.
    Clinical • P1/2 data • IO biomarker
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    IFNG (Interferon, gamma) • PLCG2 (Phospholipase C Gamma 2) • IL2 (Interleukin 2)
    |
    Imbruvica (ibrutinib) • cyclophosphamide • Calquence (acalabrutinib) • fludarabine IV • IOV-2001
    over4years
    Study of Autologous Peripheral Blood Lymphocytes in the Treatment of Patients With CLL or SLL (clinicaltrials.gov)
    P1/2, N=70, Recruiting, Iovance Biotherapeutics, Inc. | Initiation date: Oct 2019 --> Feb 2020
    Clinical • Trial initiation date
    |
    TP53 (Tumor protein P53) • IL2 (Interleukin 2)
    |
    TP53 mutation • TP53 mutation + Chr del(17p)
    |
    IOV-2001