Study of Autologous Peripheral Blood Lymphocytes in the Treatment of Patients With CLL or SLL
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
1 other identifier
interventional
7
1 country
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Feb 2020
Longer than P75 for phase_1
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 4, 2019
CompletedFirst Posted
Study publicly available on registry
November 7, 2019
CompletedStudy Start
First participant enrolled
February 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 11, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 2, 2024
CompletedDecember 24, 2025
December 1, 2025
4.7 years
November 4, 2019
December 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Phase I: RP2D (Recommended Phase 2 Dose)
to determine the recommended Phase 2 dose of IOV-2001 followed by interleukin-2 (IL-2)
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
up to two years
Secondary Outcomes (8)
Phase 1: Adverse Events
up to one year or depending on when the recommended phase 2 dose is determined
Phase 1: Disease Assessment
up to two years
Phase 1: Disease Assessment
up to two years
Phase 1: Disease Assessment
up to two years
Phase 2: Disease Assessment (Separately for each cohort)
up to two years
- +3 more secondary outcomes
Study Arms (4)
Cohort 1a
EXPERIMENTALCLL/SLL patients whose disease has relapsed or is relapsing post ibrutinib or acalabrutinib therapy. Patients will receive IOV-2001 + low dose IL-2.
Cohort 1b
EXPERIMENTALCLL/SLL patients whose disease has relapsed or is relapsing post ibrutinib or acalabrutinib therapy. Patients will receive IOV-2001 + high dose IL-2.
Cohort 2
EXPERIMENTALCLL/SLL patients with del 17p who progressed or are progressing on ibrutinib or acalabrutinib therapy. Patients will receive IOV-2001 + IL-2.
Cohort 3
EXPERIMENTALCLL/SLL patients without del 17p who progressed or progressing on ibrutinib or acalabrutinib therapy. Patients will receive IOV-2001 + IL-2.
Interventions
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
6 doses of IL-2 will follow the infusion of IOV-2001
Eligibility Criteria
You may qualify if:
- Patients with CLL or SLL with radiographically measurable disease
- Cohort 2 only: patients with progressed or progressing CLL/SLL on ibrutinib or acalabrutinib with del 17p and/or TP53 mutated
- Cohort 3 only: patients with progressed or progressing CLL/SLL on ibrutinib or acalabrutinib without del 17p and/or TP53 mutated
- Patients must have documented progression or be progressing on ibrutinib or acalabrutinib, as indicated by the presence of known BTK resistance mutation
- Patients must have received at least 1 prior regimen (only for patients without del 17p and/or TP53 mutated) and currently be on ibrutinib or acalabrutinib. For patients on combination therapy as the last line of therapy prior study entry, progression to any of the individual components of the combination therapy, rather than to the combination regimen, is required.
- For Cohort 2: The single prior regimen can be ibrutinib or acalabrutinib (ie, patients are eligible while progressing on their first line of therapy)
- For Cohort 3: Patients must have progressed on at least 1 additional line of therapy in addition to ibrutinib or acalabrutinib
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and an estimated life expectancy of ≥ 3 months.
- Patients must have adequate bone marrow function to receive NMA-LD
- Pulmonary function assessed by spirometry demonstrating FEV1 \> 50% predicted normal
- Cardiac function demonstrating left ventricular ejection fraction (LVEF) \> 45%
- Patients of childbearing potential or their partners of childbearing potential must be willing to practice an approved method of birth control during treatment and for 12 months after receiving the last protocol-related therapy.
You may not qualify if:
- Patients who have received an organ allograft or prior cell transfer therapy within 20 years.
- Patients with known or suspected transformed disease (ie, Richter's Transformation).
- Patients who received treatment with any systemic chemotherapy, immunotherapy, targeted small molecule inhibitors, or other biologic agents within 30 days or 5 half-lives, whichever is shorter, of IOV-2001 infusion with the exception of ibrutinib or acalabrutinib
- Patients with known involvement of central nervous system (CNS) by lymphoma or leukemia
- Patients who are on chronic systemic steroid therapy \>5 mg/day prednisone equivalent for any reason
- Patients who have active systemic infections requiring systemic ABX, autoimmune anemia or thrombocytopenia, coagulation disorders, or other active major medical illnesses of the cardiovascular, respiratory, or immune system.
- Patients who are seropositive for any of the following:
- Human immunodeficiency virus (HIV)-1 or HIV-2 antibodies
- Hepatitis B antigen (HbsAg) or anti-hepatitis B core total antibodies (anti-HbcAb), or hepatitis C antibody (HCVAb)
- Patients with active and chronic fungal, bacterial, or viral infection requiring IV treatment
- Patients who require treatment for anti-coagulation with a vitamin K antagonist (warfarin)
- Patients who have received a live or attenuated vaccine within 28 days of beginning the preparative NMA-LD regimen
- Patients who are pregnant or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Duke University
Durham, North Carolina, 27710, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219, United States
Ohio State University
Columbus, Ohio, 43210, United States
Allegheny Health
Pittsburgh, Pennsylvania, 15224, United States
Baptist Cancer Center
Memphis, Tennessee, 38120, United States
University of Utah, Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Iovance Biotherapeutics Medical Monitor
Iovance Biotherapeutics, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 4, 2019
First Posted
November 7, 2019
Study Start
February 19, 2020
Primary Completion
November 11, 2024
Study Completion
December 2, 2024
Last Updated
December 24, 2025
Record last verified: 2025-12