Plain-English translation of NCT05480449 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 1/2 — A combined trial that checks safety and dosing while also starting to look at whether the treatment works.
This trial is testing huCART19 cells—special immune cells grown in the lab that are trained to recognize and destroy leukemia cells. The study compares a newer, faster manufacturing method (called the CliniMACS Prodigy platform) to older methods, to see if it works safely and effectively. The hope is that by making these cells faster, patients won't have to wait as long while sick, and the treatment may work even better.
Current methods to manufacture these immune cells take a long time and require many people working by hand—during which patients often get sicker. This trial exists to test whether a newer, more automated manufacturing process can make the cells faster without sacrificing safety or effectiveness, and whether it might even help patients who didn't respond well to older versions of this treatment.
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You will have your own immune cells collected (similar to a blood donation), then sent to a lab where they are engineered to recognize leukemia cells using the new faster manufacturing method. After the cells are ready, you will receive them back as an infusion. You will then have regular visits to the hospital or clinic for blood tests, scans, and check-ups to monitor how well the treatment is working and watch for any side effects. The trial has two main phases: a dose-finding phase to determine the right amount of cells to give, followed by a larger phase where more patients receive the recommended dose.
AI-generated summary from trial data · Jun 18, 2026 · Not medical advice
United States