PERIPHERAL BLOOD LYMPHOCYTE (PBL) therapy is an adoptive cell therapy consisting of a non-genetically modified, polyclonal T cell product that is manufactured from a patient’s blood sample using a nine-day process.
The PBL therapy designated IOV-2001 is under investigation in the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL). Patients experiencing disease relapse during ibrutinib or acalabrutinib therapy treatment are eligible. Preclinical studies of IOV-2001 have shown activity against autologous leukemia cancer cells, while treatment with ibrutinib and acalabrutinib have has been demonstrated to improve the proliferation and effector functions of the IOV-2001 manufactured product.
To generate IOV-2001, a 50 mL blood sample is collected from each patient, and millions of patient-specific T cells are expanded and rejuvenated from blood during a nine-day manufacturing process. The PBL cells are cryopreserved and sent to the patient’s treatment center. Patients receive a pre-conditioning therapy to reduce the immune suppressive environment of their cancer and then receive the expanded T cells via intravenous infusion. The IOV-2001 PBL treatment is intended to target, infiltrate and attack the patient’s cancer with a greater number of T cells. Immediately following infusion, patients receive interleukin 2 (IL-2) to support growth and activation of the PBL cells and augment anti-cancer activity in the patient.
CLINICAL TRIAL OVERVIEW
IOV-CLL-01 is a Phase 1/2 study to evaluate the safety and efficacy of autologous PBL therapy IOV-2001 in patients with relapsed or refractory CLL/SLL.
There are several objectives to the trial, some of which aim to determine:
- Whether IOV-2001 reduces or slows the progression of CLL/SLL
- Whether IOV-2001 eliminates all detectable CLL/SLL disease
- Whether treatment with IOV-2001 extends the life of a patient without their cancer worsening.
IOV-2001 is an investigational therapy that is being tested in clinical studies and has not been approved by the FDA or any other agency for any indication. A clinical trial is designed to explore efficacy and safety of experimental therapies. You should talk to your doctor about the benefits and risks of participating in this trial.
YOU MAY QUALIFY FOR THE TRIAL IF:
- You have been diagnosed with CLL/SLL, and
- You have relapsed or are relapsing during treatment with ibrutinib or acalabrutinib therapy
- You have received at least 1 prior regimen and are currently receiving ibrutinib or acalabrutinib therapy
- You are between 18 to 70 years old
If you satisfy these key eligibility criteria, you may be eligible to participate in this clinical trial. There are other additional eligibility criteria that can only be assessed by a trial physician.
To learn more about the trial, please call: 1-866-565-4410
Further details for healthcare providers can be accessed below:
To view a list of active trial sites, please visit https://www.clinicaltrials.gov/ct2/show/NCT04155710.