A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability, and Efficacy of Vididencel in Chronic Phase Chronic Myeloid Leukemia Patients with Measurable Residual Disease

The primary objective of this phase 1 trial is to evaluate the safety, tolerability, and efficacy of vididencel in patients diagnosed with chronic phase chronic myeloid leukemia. This investigation focuses on individuals presenting with measurable residual disease who have failed to achieve the necessary criteria for treatment-free remission while undergoing tyrosine kinase inhibitor therapy. 4, 5

The sponsor did not provide information regarding the total number of participants. The study population consists of patients diagnosed with chronic phase chronic myeloid leukemia. The cohort includes both male and female individuals. Based on the provided age range codes, the subjects fall within specific developmental or adult age categories. No further information regarding lifestyle considerations or specific inclusion and exclusion criteria was disclosed.

This Phase 1, open-label, single-arm trial is designed to evaluate the safety, tolerability, and efficacy of vididencel in patients diagnosed with chronic phase chronic myeloid leukemia. The study focuses on individuals presenting with measurable residual disease who are unable to meet the requirements for treatment-free remission while undergoing tyrosine kinase inhibitor therapy. The clinical investigation involves a screening visit to determine eligibility, followed by scheduled study visits to monitor clinical outcomes. The total duration of the trial is estimated to span from March 2026 to March 2030.

The clinical trial focuses on the evaluation of efficacy in patients diagnosed with chronic phase chronic myeloid leukemia. The assessment protocols are designed to monitor disease activity and therapeutic response throughout the study period.