AACR 2021: T-Cell Infusion Product Under Investigation in Resistant CLL
Posted: Friday, April 16, 2021
Although many patients treated with Bruton’s tyrosine kinase inhibitors approved for chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma achieve durable responses, other effective therapies are needed for those who relapse. Thus, John C. Byrd, MD, of The Ohio State University Comprehensive Cancer Center, Columbus, and colleagues studied adoptive cell transfer of IOV-2001—a polyclonal and nongenetically modified autologous T-cell infusion product—in patients whose hematologic malignancy has progressed on ibrutinib or acalabrutinib. Details of the study design were announced during the virtual edition of the American Association for Cancer Research (AACR) Annual Meeting 2021 (Abstract CT244).
In this ongoing, first-in-patient, phase I/II study, IOV-2001 is reproducibly generated from 50 mL of blood obtained from the patient over a 9-day manufacturing duration to yield billions of peripheral blood lymphocytes. Patients will be enrolled from up to five clinical sites in North America (with a goal of somewhere between 39 and 70 patients).
In the first phase of the study, the investigators will attempt to identify the recommended phase II dose via dose de-escalation guided by dose-limiting toxicities. Also, cohort 1a will receive the immunotherapy followed by up to six doses of subcutaneous low-dose IL-2 (9 mIU) every 8 to 12 hours; cohort 1b will receive the immunotherapy followed by up to six doses of intravenous high-dose IL-2 (600,000 IU/kg) every 8 to 12 hours. In the second phase of the study, immunotherapy will be given at the recommended phase II dose followed by up to six doses of the selected IL-2 dose. Then, patients will be categorized into cohorts with and without del(17p) and/or TP53 mutation.
Disclosure: Dr. Byrd reported no conflicts of interest. For disclosures of the other study authors, visit abstractsonline.com.