7 Participants Needed

Autologous Immune Cell Therapy for Leukemia

Recruiting at 6 trial locations
IB
Overseen ByIovance Biotherapeutics Clinical Inquiries
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Iovance Biotherapeutics, Inc.
Must be taking: Ibrutinib, Acalabrutinib
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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 on the Research Team?

IB

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.
See 9 more

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.
See 8 more

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?
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Iovance Biotherapeutics, Inc.

Lead Sponsor

Trials
26
Recruited
1,800+
Unbiased ResultsWe believe in providing patients with all the options.
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