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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 Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

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Dr. Javier Pinilla Ibarz and colleagues presented this research at the American Society for Hematology annual meeting, which was held in December 2021 (ASH 2021).

Background:

Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are associated with T-cell dysfunction or “exhaustion.” T-cell dysfunction can impair the ability of T-cells to recognize and eliminate cancer cells and increase susceptibility to infections.

Immunotherapy is a therapy that can stimulate or suppress the immune system to help the body fight cancer, infection, and other diseases. Adoptive cell transfer is a type of immunotherapy in which T cells are given to a patient to help the body fight diseases, such as cancer. T cells can be taken from the patient’s blood and modified in the lab (ie, CAR-T therapy) or taken from a donor.

Interestingly, ibrutinib treatment has been shown to improve T-cell number and function. The company Iovance has developed an autologous, non-genetically modified, polyclonal T-cell product (IOV-2001) from BTK-inhibitor-treated patients with CLL, consisting of billions of peripheral blood lymphocytes (PBLs). In preclinical (before use in humans) studies, IOV-2001 showed more potent anti-tumor activity against leukemia cells compared with pre-ibrutinib treatment PBLs.

Takeaways:

  • IOV-CLL-01 is an ongoing, first-in-patient, Phase 1/2, dose-finding study designed to evaluate the safety and efficacy of IOV-2001 in patients with CLL/SLL who are progressing or have progressed on ibrutinib or acalabrutinib treatment.
  • Approximately 39 to 70 patients will be enrolled at study sites in North America.
  • Patients must be between 18-70 years of age and currently on ibrutinib or acalabrutinib with progressed or progressing CLL/SLL.
  • Phase 1 will evaluate the safety and determine the recommended dose for Phase 2.
  • Phase 2 will evaluate efficacy (objective response rate) and safety.
  • After screening and enrollment, patients will have 50 mL of blood drawn to generate PBLs in a 9-day manufacturing process.
  • Treatment consists of a preparative chemotherapy regimen for three days, followed by two days of rest, a single infusion of IOV-2001, and six doses of either low-dose or high-dose interleukin-2.

Conclusions:

This clinical trial is the first time the novel immunotherapy IOV-2001 is being tested in humans, so we have much to learn about its safety and efficacy. If you are interested in learning more or participating in the trial, more details can be found here.

Here is the link to the ASH 2021 abstract for more details.

Take care of yourself first.

Ann Liu, PhD

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