B-Cell Non-Hodgkin Lymphoma Patients Begin Treatment with Axicabtagene Ciloleucel in Phase 2 Trial

B-Cell Non-Hodgkin Lymphoma Patients Begin Treatment with Axicabtagene Ciloleucel in Phase 2 Trial

Patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma (iNHL) have begun treatment with axicabtagene ciloleucel (axi-cel) in the Phase 2 ZUMA-5 trial, the immunotherapy’s developer, Kite Pharma, announced. The trial (NCT03105336) is currently recruiting participants in the U.S.

Kite, a leading player in the field of cell therapy, is continuing its studies of axi-cel after positive results in an earlier clinical study published in the journal Blood.

The research, “B-cell Depletion and Remissions of malignancy along with cytokine-associated toxicity in a clinical trial of anti-CD19 chimeric-antigen-receptor-transduced T cells,” reported a high response rate and increased disease remission in patients with relapsed or refractory iNHL who received treatment with axi-cel (NCT00924326).

Axi-cel is an investigational therapy for patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (NHL) who are ineligible for autologous stem cell transplant, a type of transplant that uses a person’s own stem cells.

In this type of treatment, patients’ T-cells, an important group of cells in our immune system, are removed and modified to express the chimeric antigen receptor (CAR) targeting CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemia. This strategy redirects T-cells against cancer cells so that they can recognize and kill diseased cells once reintroduced into patients.

Currently, the U.S. Food and Drug Administration (FDA) is reviewing axi-cel for aggressive non-Hodgkin’s lymphoma. The therapy already has received breakthrough therapy designation for diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL).

The Phase 2 ZUMA-5 trial aims to enroll 50 adult patients with iNHL whose disease relapsed within two years of first-line treatment, is refractory to second-line or greater therapy, or has relapsed at any point after transplant. The trial will determine patients’ response to treatment with axi-cel and assess if the therapy is safe. The primary endpoint will evaluate patients’ objective response rate, with researchers targeting a rate of 70%.

“Despite recent advances in the treatment of NHL, iNHL generally remains an incurable disease. As a result, there is a great unmet need in patients with high-risk disease which is why the focus of this study has the opportunity to make a difference,” David Chang, MD, PhD, executive vice president of research and development and chief medical officer at Kite, said in a press release. “The dosing of the first patient in ZUMA-5 marks an important milestone in our commitment to serving patients. We will continue to explore the potential for axi-cel to treat hematologic malignancies beyond aggressive NHL, the foundation of our CAR-T program.”

Patricia holds her Ph.D. in Cell Biology from University Nova de Lisboa, and has served as an author on several research projects and fellowships, as well as major grant applications for European Agencies. She also served as a PhD student research assistant in the Laboratory of Doctor David A. Fidock, Department of Microbiology & Immunology, Columbia University, New York.
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Patricia holds her Ph.D. in Cell Biology from University Nova de Lisboa, and has served as an author on several research projects and fellowships, as well as major grant applications for European Agencies. She also served as a PhD student research assistant in the Laboratory of Doctor David A. Fidock, Department of Microbiology & Immunology, Columbia University, New York.

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