Study of Autologous Peripheral Blood Lymphocytes in the Treatment of Patients With CLL or SLL
NCT ID: NCT04155710
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
7 participants
INTERVENTIONAL
2020-02-19
2024-12-02
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Cohort 1a
CLL/SLL patients whose disease has relapsed or is relapsing post ibrutinib or acalabrutinib therapy. Patients will receive IOV-2001 + low dose IL-2.
IOV-2001
Adoptive cell therapy (ACT) manufactured from peripheral blood lymphocytes (PBL). The final investigational product is a cryopreserved cell suspension.
Low dose IL-2
6 doses of subcutaneous (SC) LD-IL-2 (9 MIU every 8-12 hours) will follow the infusion of IOV-2001
Cohort 1b
CLL/SLL patients whose disease has relapsed or is relapsing post ibrutinib or acalabrutinib therapy. Patients will receive IOV-2001 + high dose IL-2.
IOV-2001
Adoptive cell therapy (ACT) manufactured from peripheral blood lymphocytes (PBL). The final investigational product is a cryopreserved cell suspension.
High dose IL-2
6 doses of IV HD-IL-2 (600,000 IU/kg Q8-12H will follow the infusion of IOV-2001
Cohort 2
CLL/SLL patients with del 17p who progressed or are progressing on ibrutinib or acalabrutinib therapy. Patients will receive IOV-2001 + IL-2.
IOV-2001
Adoptive cell therapy (ACT) manufactured from peripheral blood lymphocytes (PBL). The final investigational product is a cryopreserved cell suspension.
IL-2
6 doses of IL-2 will follow the infusion of IOV-2001
Cohort 3
CLL/SLL patients without del 17p who progressed or progressing on ibrutinib or acalabrutinib therapy. Patients will receive IOV-2001 + IL-2.
IOV-2001
Adoptive cell therapy (ACT) manufactured from peripheral blood lymphocytes (PBL). The final investigational product is a cryopreserved cell suspension.
IL-2
6 doses of IL-2 will follow the infusion of IOV-2001
Interventions
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IOV-2001
Adoptive cell therapy (ACT) manufactured from peripheral blood lymphocytes (PBL). The final investigational product is a cryopreserved cell suspension.
Low dose IL-2
6 doses of subcutaneous (SC) LD-IL-2 (9 MIU every 8-12 hours) will follow the infusion of IOV-2001
High dose IL-2
6 doses of IV HD-IL-2 (600,000 IU/kg Q8-12H will follow the infusion of IOV-2001
IL-2
6 doses of IL-2 will follow the infusion of IOV-2001
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
2. Patients must have documented progression or be progressing on ibrutinib or acalabrutinib, as indicated by the presence of known BTK resistance mutation
3. 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
4. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and an estimated life expectancy of ≥ 3 months.
5. Patients must have adequate bone marrow function to receive NMA-LD
6. Pulmonary function assessed by spirometry demonstrating FEV1 \> 50% predicted normal
7. Cardiac function demonstrating left ventricular ejection fraction (LVEF) \> 45%
8. 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.
Exclusion Criteria
2. Patients with known or suspected transformed disease (ie, Richter's Transformation).
3. 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
4. Patients with known involvement of central nervous system (CNS) by lymphoma or leukemia
5. Patients who are on chronic systemic steroid therapy \>5 mg/day prednisone equivalent for any reason
6. 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.
7. 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)
8. Patients with active and chronic fungal, bacterial, or viral infection requiring IV treatment
9. Patients who require treatment for anti-coagulation with a vitamin K antagonist (warfarin)
10. Patients who have received a live or attenuated vaccine within 28 days of beginning the preparative NMA-LD regimen
11. Patients who are pregnant or breastfeeding
18 Years
70 Years
ALL
No
Sponsors
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Iovance Biotherapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Iovance Biotherapeutics Medical Monitor
Role: STUDY_CHAIR
Iovance Biotherapeutics, Inc.
Locations
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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
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
Countries
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Other Identifiers
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IOV-CLL-01
Identifier Type: -
Identifier Source: org_study_id