Autologous Immune Cell Therapy for Leukemia

No longer recruiting at 6 trial locations

Overseen By Iovance Biotherapeutics Clinical Inquiries

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Iovance Biotherapeutics, Inc.

Must be taking: Ibrutinib, Acalabrutinib

Must not be taking: Systemic steroids, Warfarin

Disqualifiers: Organ allograft, CNS involvement, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called IOV-2001, which uses immune cell therapy to combat chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). It targets individuals whose condition has returned or worsened despite treatment with drugs like ibrutinib or acalabrutinib. The trial will assess the effectiveness of IOV-2001, both alone and with varying doses of another drug, IL-2, across different patient groups. Suitable candidates have CLL or SLL, are currently on ibrutinib or acalabrutinib, and have experienced disease progression during treatment. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Do I have to stop taking my current medications for the trial?

The trial does not require you to stop taking ibrutinib or acalabrutinib, as these are part of the eligibility criteria. However, you must not have received other systemic chemotherapy, immunotherapy, or biologic agents within 30 days before the trial, except for ibrutinib or acalabrutinib.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that treatments like IOV-2001, used with IL-2, are still under study to assess their safety in people. Although specific safety data from earlier studies is not available, the treatment is currently being tested in a Phase 1/2 trial.

This phase of a trial typically evaluates how well people tolerate a new treatment and identifies any side effects. As IOV-2001 is in this stage, researchers are gathering information on its safety and how people respond to it.

Reaching this phase often indicates that earlier tests suggested potential safety. However, a complete understanding will emerge only as more data is collected from the ongoing trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about IOV-2001 for treating leukemia, specifically chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL), because it offers a unique approach compared to standard options like chemotherapy, targeted therapies such as ibrutinib or acalabrutinib, and immunotherapy. IOV-2001 is an autologous immune cell therapy, meaning it uses a patient's own immune cells to fight cancer, potentially reducing the risk of severe side effects associated with foreign substances. This therapy is combined with interleukin-2 (IL-2), which helps boost the activity of these immune cells, offering a targeted attack on cancer cells. Unlike traditional treatments that can take longer to show results, this approach might offer a more rapid response due to its personalized and direct mechanism of action.

What evidence suggests that IOV-2001 might be an effective treatment for CLL/SLL?

Studies have shown that IOV-2001, a treatment using a patient’s own immune cells, holds promise for treating Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL). This trial will evaluate IOV-2001 in combination with IL-2, a protein that promotes immune cell growth, across different cohorts. Participants will receive IOV-2001 with either low or high doses of IL-2, depending on their specific cohort. Research indicates that combining IOV-2001 with IL-2 may benefit patients whose cancer has returned after treatment with drugs like ibrutinib or acalabrutinib. Early findings suggest this approach can help control the disease by targeting and killing cancer cells. While more research is needed, these initial signs are hopeful. ^{1 2 4 6 7}

Who Is on the Research Team?

Iovance Biotherapeutics Medical Monitor

Principal Investigator

Iovance Biotherapeutics, Inc.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have tried at least one treatment after ibrutinib or acalabrutinib and my condition worsened.

My cancer is getting worse despite taking ibrutinib or acalabrutinib.

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

Exclusion Criteria

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

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

I haven't had chemotherapy, immunotherapy, or similar treatments in the last 30 days or 5 half-lives, except for ibrutinib or acalabrutinib.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Treatment

Patients receive a nonmyeloablative lymphocyte depleting preparative regimen followed by infusion of IOV-2001 and IL-2 administration

up to 1 year

Phase 2 Treatment

Evaluation of the recommended Phase 2 dose (RP2D) of IOV-2001 followed by IL-2 in selected patient cohorts

up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• IOV-2001

Trial Overview 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.

How Is the Trial Designed?

Group I: Cohort 3 Experimental Treatment 2 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 2 Experimental Treatment 2 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 1b Experimental Treatment 2 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 1a Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

Iovance Biotherapeutics, Inc.

Lead Sponsor

Trials

26

Recruited

1,800+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04155710

NCT04155710 | Study of Autologous Peripheral Blood ... 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 ...

2. cllsociety.org cllsociety.org/2022/09/ash-2021-trial-in-progress-phase-1-2-study-evaluating-the-safety-and-efficacy-of-iov-2001-an-autologous-non-genetically-modified-polyclonal-t-cell-product-in-patients-with-relapsed-or-refractory-chron/

ASH 2021: Trial in Progress: Phase 1/2 Study Evaluating ... ASH 2021: Trial in Progress: Phase 1/2 Study Evaluating the Safety and Efficacy of IOV-2001, an Autologous, Non-Genetically Modified, Polyclonal ...

3. iovance.com iovance.com/uploads/Iovance_ASH-2021_IOV-CLL-01-TiP.pdf

3846 ash 2021 Inclusion Criteria – All Patients. • ≥18 years of age, ECOG performance status of 0 or 1, and an estimated life expectancy of ≥3 months.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3507531/

Autologous Stem Cell Transplantation for Chronic ... Although autoSCT can prolong event and progression-free survival if used as part of early front-line treatment, it does not improve overall survival.

5. iovance.com iovance.com/uploads/AACR_2021_ePoster_IOV-CLL-01_TiP.pdf

ct244 aacr 2021 IOV-CLL-01 (NCT04155710) is an ongoing first-in-patient, Phase 1/2, open-label, multi-cohort, dose-finding study designed to evaluate the safety ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0006497121057633

Phase 1/2 Study Evaluating the Safety and Efficacy of Iov- ... IOV-CLL-01 (NCT04155710) is an ongoing, first-in-patient, Phase 1/2, open-label, multi-cohort, dose-finding study designed to evaluate the safety and efficacy ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11984025/

Immunotherapy in chronic lymphocytic leukemia The advent of immunotherapy has revolutionized the prognosis of CLL, advancing treatment modalities and offering substantial benefits to patient outcomes.