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Chronic Lymphocytic LeukemiaPhase 1NCT04155710

Study of Autologous Peripheral Blood Lymphocytes in the Treatment of Patients With CLL or SLL

A Phase 1 study testing IOV-2001, Low dose IL-2 and High dose IL-2 in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Iovance Biotherapeutics, Inc. at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
IOV-2001, Low dose IL-2 and High dose IL-2
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
7 sitesUnited States
Study dates
19 Feb 2020to 2 Dec 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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.

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

  • Ohio State University

    Columbus, Ohio, 43210

  • Duke University

    Durham, North Carolina, 27710

  • Baptist Cancer Center

    Memphis, Tennessee, 38120

  • Allegheny Health

    Pittsburgh, Pennsylvania, 15224

  • University of Utah, Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: 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 patients with CLL/SLL, which has relapsed or is relapsing during treatment with ibrutinib or acalabrutinib.

Read the detailed description

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.

Being tested
IOV-2001, Low dose IL-2, High dose IL-2, IL-2
Keywords
Autologous Peripheral Blood Lymphocytes, PBL, IOV-2001, CLL, IL-2, Adoptive Cell Therapy, SLL
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IOV-2001Biological

    Also called Autologous PBL

    Adoptive cell therapy (ACT) manufactured from peripheral blood lymphocytes (PBL). The final investigational product is a cryopreserved cell suspension.

  • Low dose IL-2Drug

    Also called Interleukin-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-2Drug

    Also called Interleukin-2

    6 doses of IV HD-IL-2 (600,000 IU/kg Q8-12H will follow the infusion of IOV-2001

  • IL-2Drug

    Also called Interleukin-2

    6 doses of IL-2 will follow the infusion of IOV-2001

Study groups in NCT04155710
Study groupRoleWhat they receive
Cohort 1aExperimentalCLL/SLL patients whose disease has relapsed or is relapsing post ibrutinib or acalabrutinib therapy. Patients will receive IOV-2001 + low dose IL-2.
Receives: Biological: IOV-2001; Drug: Low dose IL-2
Cohort 1bExperimentalCLL/SLL patients whose disease has relapsed or is relapsing post ibrutinib or acalabrutinib therapy. Patients will receive IOV-2001 + high dose IL-2.
Receives: Biological: IOV-2001; Drug: High dose IL-2
Cohort 2ExperimentalCLL/SLL patients with del 17p who progressed or are progressing on ibrutinib or acalabrutinib therapy. Patients will receive IOV-2001 + IL-2.
Receives: Biological: IOV-2001; Drug: IL-2
Cohort 3ExperimentalCLL/SLL patients without del 17p who progressed or progressing on ibrutinib or acalabrutinib therapy. Patients will receive IOV-2001 + IL-2.
Receives: Biological: IOV-2001; Drug: IL-2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase I: RP2D (Recommended Phase 2 Dose)

    to determine the recommended Phase 2 dose of IOV-2001 followed by interleukin-2 (IL-2)

    Measured: up to one year or depending on when the recommended phase 2 dose is determined

  2. 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

    Measured: up to two years

Secondary outcomes (8)

  1. Phase 1: Adverse Events

    Incidence of adverse events (AEs) and serious AEs

    Measured: up to one year or depending on when the recommended phase 2 dose is determined

  2. Phase 1: Disease Assessment

    To assess the evidence of activity of IOV-2001 followed by IL-2 as measured by ORR per Investigator assessment

    Measured: up to two years

  3. 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

    Measured: up to two years

  4. Phase 1: Disease Assessment

    To assess minimum residual disease (MRD)-negative rate for IOV-2001 followed by IL-2

    Measured: up to two years

  5. Phase 2: Disease Assessment (Separately for each cohort)

    To assess progression free survival (PFS) of IOV-2001 therapy followed by IL-2

    Measured: up to two years

  6. Phase 2: Disease Assessment (Separately for each cohort)

    To assess overall survival (OS) of IOV-2001 therapy followed by IL-2

    Measured: up to two years

  7. Phase 2: Disease Assessment (Separately for each cohort)

    To assess duration of response (DOR) of IOV-2001 therapy followed by IL-2

    Measured: up to two years

  8. Phase 2: Disease Assessment (Separately for each cohort)

    To assess disease control rate (DCR) of IOV-2001 therapy followed by IL-2

    Measured: up to two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2019
  2. Study start19 Feb 2020
  3. Primary completion11 Nov 2024
  4. Study completion2 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04155710
Sponsor's protocol ID
IOV-CLL-01
Status last verified
Dec 2025
First submitted
4 Nov 2019
Last updated
24 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IOV-2001, Low dose IL-2 and High dose IL-2 in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Iovance Biotherapeutics, Inc. at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase I: RP2D (Recommended Phase 2 Dose) (time frame: up to one year or depending on when the recommended phase 2 dose is determined). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04155710.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.

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