This is a Phase 1/2, study evaluating IOV-2001 (Adoptive Cell Therapy) composed of autologous PBL (Peripheral Blood Lymphocytes) in patients with CLL/SLL, which has relapsed or is relapsing during treatment with ibrutinib or acalabrutinib.
This study involves patients receiving nonmyeloablative (NMA) lymphocyte depleting (LD) preparative regimen prior to infusion of IOV-2001 followed by IL-2 administration. In Phase 1, patients meeting the eligibility criteria will be enrolled and will receive treatment with IOV-2001 followed by low dose IL-2 or high dose IL-2. After completion of Phase 1, the recommended Phase 2 dose (RP2D) will be evaluated in selected patient cohorts defined in the Phase 2 part of the study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Adoptive cell therapy (ACT) manufactured from peripheral blood lymphocytes (PBL). The final investigational product is a cryopreserved cell suspension.
6 doses of subcutaneous (SC) LD-IL-2 (9 MIU every 8-12 hours) will follow the infusion of IOV-2001
6 doses of IV HD-IL-2 (600,000 IU/kg Q8-12H will follow the infusion of IOV-2001
Moffitt Cancer Center
Tampa, Florida, United States
Duke University
Durham, North Carolina, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Phase I: RP2D (Recommended Phase 2 Dose)
to determine the recommended Phase 2 dose of IOV-2001 followed by interleukin-2 (IL-2)
Time frame: up to one year or depending on when the recommended phase 2 dose is determined
Phase 2: Objective Response Rate
To evaluate efficacy of the RP2D of IOV-2001 followed by IL-2 as measured by objective response rate (ORR) per investigator assessment
Time frame: up to two years
Phase 1: Adverse Events
Incidence of adverse events (AEs) and serious AEs
Time frame: up to one year or depending on when the recommended phase 2 dose is determined
Phase 1: Disease Assessment
To assess the evidence of activity of IOV-2001 followed by IL-2 as measured by ORR per Investigator assessment
Time frame: up to two years
Phase 1: Disease Assessment
To assess CR/CRi rate per Investigator as defined by International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria for IOV-2001 followed by IL-2
Time frame: up to two years
Phase 1: Disease Assessment
To assess minimum residual disease (MRD)-negative rate for IOV-2001 followed by IL-2
Time frame: up to two years
Phase 2: Disease Assessment (Separately for each cohort)
To assess progression free survival (PFS) of IOV-2001 therapy followed by IL-2
Time frame: up to two years
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6 doses of IL-2 will follow the infusion of IOV-2001
Allegheny Health
Pittsburgh, Pennsylvania, United States
Baptist Cancer Center
Memphis, Tennessee, United States
University of Utah, Huntsman Cancer Institute
Salt Lake City, Utah, United States
Phase 2: Disease Assessment (Separately for each cohort)
To assess overall survival (OS) of IOV-2001 therapy followed by IL-2
Time frame: up to two years
Phase 2: Disease Assessment (Separately for each cohort)
To assess duration of response (DOR) of IOV-2001 therapy followed by IL-2
Time frame: up to two years
Phase 2: Disease Assessment (Separately for each cohort)
To assess disease control rate (DCR) of IOV-2001 therapy followed by IL-2
Time frame: up to two years