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A Phase 1/2 Study Evaluating the Safety and Efficacy of IOV-2001 in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
This is a Phase 1/2, study evaluating IOV-2001 (Adoptive Cell Therapy) composed of autologous PBL (Peripheral Blood Lymphocytes) in patient with CLL/SLL, which has relapsed or is relapsing during treatment with ibrutinib.
Primary Objectives: Phase 1 (Cohorts 1a, 1b): To determine the RP2D of IOV-2001 followed by IL-2 Phase 2 (Cohorts 2 and 3): To evaluate efficacy of the RP2D of IOV-2001 followed by IL-2, as measured by ORR per Investigator assessment Secondary Objectives: Phase 1 (Cohorts 1a, 1b): Secondary objective analysis will be performed separately for patients receiving LD-IL-2 and HD-IL-2: -to evaluate the safety of IOV-2001 followed by IL-2 -to assess the evidence of activity of IOV-2001 followed by IL-2 as measured by ORR per Investigator assessment -to assess progression-free survival (PFS), OS, duration of response (DOR), disease control rate (DCR), complete remission (CR), complete remission with incomplete marrow recovery (CRi), partial remission (PR), and stable disease (SD), of IOV-2001 followed by IL-2 -to assess CR/CRi rate per independent review as defined by International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria for IOV-2001 followed by IL-2 -to assess minimum residual disease (MRD)-negative rate for IOV-2001 followed by IL-2 Phase 2 (Cohorts 2 and 3): separately for patients in each cohort: -to assess PFS of IOV-2001 therapy -to assess OS of IOV-2001 therapy -to assess DOR of IOV-2001 therapy -to assess the DCR of IOV-2001 therapy -to assess CR/CRi rate per independent review as defined by iwCLL 2018 criteria of IOV-2001 therapy -to assess MRD-negative rate of IOV-2001 therapy -to further define the safety profile of IOV-2001 therapy Exploratory Objectives (Phases 1 and 2): -to study the in vitro characteristics and the in vivo persistence of IOV-2001, which may affect response, outcome, and toxicity of treatment -to assess the potential immune correlates of the treatment -to explore the properties of the disease that may correlate with IOV-2001 activity
IL-2 (Interleukin-2); IOV-2001 (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)