What side effects are associated with this type of intervention?

Common treatments for lymphoma, particularly those involving adoptive cell therapy and autologous hematopoietic cell transplantation, can have several side effects. These include cytokine release syndrome (CRS), which may cause fever, fatigue, and muscle pain; neurotoxicity, leading to confusion, headaches, and seizures; and infections due to immunosuppression. Other side effects can include graft-versus-host disease (GVHD) in allogeneic transplants, causing skin rashes, liver dysfunction, and gastrointestinal issues, as well as general chemotherapy-related side effects such as nausea, vomiting, and hair loss.

What prior FDA approvals exist?

The FDA has approved several adoptive cell therapies for the treatment of lymphoma, particularly CAR T-cell therapies targeting CD19. Notable examples include axicabtagene ciloleucel (Yescarta) and tisagenlecleucel (Kymriah), both of which have shown durable remissions in patients with relapsed or refractory large B-cell lymphoma. These therapies involve modifying a patient's own T cells to enhance their ability to target and kill cancer cells, similar to the approach being studied in the IOV-2001 trial with autologous peripheral blood lymphocytes.

What other types of research exist?

Promising novel alternatives to IOV-2001 for Lymphoma patients in 2024 include: 1) CAR T-cell therapies targeting CD19, which have shown durable remissions in large B-cell lymphoma (LBCL) and are being considered as a potential new standard for second-line treatment. 2) High-dose chemotherapy followed by autologous hematopoietic cell transplantation (HCT), which is effective for patients achieving complete remission (CR) after treatment of relapsed disease. 3) Nonmyeloablative or reduced-intensity allogeneic HCT, which offers a chance of long-term disease-free remission with a higher efficacy compared to conventional therapies.

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Adoptive Cell Therapy

Autologous Immune Cell Therapy for Leukemia

Phase 1 & 2

Waitlist Available

Research Sponsored by Iovance Biotherapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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 an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and an estimated life expectancy of ≥ 3 months.

Must not have

Patients with active and chronic fungal, bacterial, or viral infection requiring IV treatment

Patients who have received an organ allograft or prior cell transfer therapy within 20 years.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to two years

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a patient's own enhanced immune cells to treat CLL/SLL that has come back despite standard treatments. The process involves collecting the patient's immune cells, enhancing them in a lab, and then reinfusing them to help fight the cancer.

Who is the study for?

This trial is for patients with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) who have measurable disease and are not responding well to treatments like ibrutinib or acalabrutinib. Participants should be in fairly good health, with a performance status of 0 or 1, meaning they're fully active or restricted in physically strenuous activity but can do light work. They must also have proper heart and lung function and agree to use birth control.

What is being tested?

The study is testing IOV-2001, an Adoptive Cell Therapy using the patient's own Peripheral Blood Lymphocytes (PBL), combined with different doses of IL-2. It aims to see how well this treatment works for those whose CLL/SLL has relapsed during current therapies. The trial includes multiple cohorts based on genetic mutations and previous treatments.

What are the potential side effects?

Potential side effects may include reactions related to the immune system such as fever, chills, weakness, infection risk increase due to low blood cell counts; issues from high-dose IL-2 like low blood pressure, fluid buildup; plus general discomfort at infusion sites.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is getting worse despite taking ibrutinib or acalabrutinib.

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I can care for myself and doctors expect me to live at least 3 more months.

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My heart pumps well, with an ejection fraction over 45%.

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My bone marrow functions well enough for treatment.

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I have CLL or SLL that can be seen on scans.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently receiving IV treatment for a long-term infection.

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I have had an organ transplant or cell therapy in the last 20 years.

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I have not received a live vaccine in the last 28 days.

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I take more than 5 mg/day of steroids for a chronic condition.

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I do not have active infections, blood disorders, or major illnesses affecting my heart, lungs, or immune system.

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My cancer has spread to my brain or spinal cord.

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I need treatment with a blood thinner like warfarin.

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My condition has changed into a more aggressive form.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to one year or depending on when the recommended phase 2 dose is determined

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to one year or depending on when the recommended phase 2 dose is determined

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to one year or depending on when the recommended phase 2 dose is determined for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase 2: Objective Response Rate

Phase I: RP2D (Recommended Phase 2 Dose)

Secondary study objectives

Phase 1: Adverse Events

Phase 1: Disease Assessment

Phase 2: Disease Assessment (Separately for each cohort)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Cohort 3Experimental Treatment2 Interventions

CLL/SLL patients without del 17p who progressed or progressing on ibrutinib or acalabrutinib therapy. Patients will receive IOV-2001 + IL-2.

Group II: Cohort 2Experimental Treatment2 Interventions

CLL/SLL patients with del 17p who progressed or are progressing on ibrutinib or acalabrutinib therapy. Patients will receive IOV-2001 + IL-2.

Group III: Cohort 1bExperimental Treatment2 Interventions

CLL/SLL patients whose disease has relapsed or is relapsing post ibrutinib or acalabrutinib therapy. Patients will receive IOV-2001 + high dose IL-2.

Group IV: Cohort 1aExperimental Treatment2 Interventions

CLL/SLL patients whose disease has relapsed or is relapsing post ibrutinib or acalabrutinib therapy. Patients will receive IOV-2001 + low dose IL-2.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

IL-2

2007

Completed Phase 4

~1100

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for lymphoma include chemotherapy, radiation therapy, and various forms of immunotherapy. Chemotherapy uses drugs to kill rapidly dividing cancer cells, while radiation therapy uses high-energy rays to target and destroy cancerous tissues. Immunotherapy, such as CAR-T cell therapy and adoptive cell therapy like IOV-2001, harnesses the patient's immune system to fight cancer. In adoptive cell therapy, immune cells (e.g., peripheral blood lymphocytes) are collected, modified or expanded in the lab, and then reintroduced into the patient to enhance the immune response against lymphoma cells. This approach is significant for lymphoma patients as it offers a targeted treatment option that can potentially lead to long-term remission with fewer side effects compared to traditional therapies.