Autologous Immune Cell Therapy for Leukemia

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

7 Participants Needed

Trial Summary

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.

Research Team

Iovance Biotherapeutics Medical Monitor

Principal Investigator

Iovance Biotherapeutics, Inc.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+