KU Researchers Launch First-in-Human Trial of In-House Manufactured “Triple Threat” CAR T Cells
Researchers at the Midwest Stem Cell Therapy Center (MSCTC) at the University of Kansas Medical Center have reached a groundbreaking milestone: the successful in-house manufacturing of a novel “Triple Threat” CAR T-cell therapy, now being evaluated in a Phase I, first-in-human clinical trial at The University of Kansas Cancer Center. Importantly, MSCTC was established and continues to be supported through funding from the Kansas Legislature, underscoring the state’s commitment to advancing cutting-edge cell and gene therapies for Kansans and beyond.
Since the FDA first approved CAR T-cell therapy in 2017, this revolutionary treatment has transformed outcomes for patients with otherwise untreatable leukemias, lymphomas, and myelomas. CAR T therapy works by taking a patient’s own immune T cells, reprogramming them in the laboratory to better recognize cancer, and then reinfusing them to hunt down diseased cells.
Yet, as powerful as this therapy has been, not all patients respond, and many relapse when cancers learn to shed or hide the single marker that traditional CAR T cells are trained to detect.
Leadership in CAR T Manufacturing at MSCTC
The new “Triple Threat” CAR T-cell is designed to solve this problem. Instead of recognizing just one target, it can detect three distinct antigens (targets) on cancer cells, making it much harder for the disease to escape.
This milestone reflects the vision of Sunil Abhyankar, MD, Medical Director of MSCTC, who led the effort to establish CAR T-cell manufacturing capacity at KU Medical Center in the GMP lab of the MSCTC. With this achievement, MSCTC joins a select group of academic centers nationwide equipped to produce gene-modified cell therapies under FDA-regulated Good Manufacturing Practices (GMP).
Dr. Abhyankar leads the MSCTC team, which includes Ramesh Balusu, PhD, Scientific Director, and Rupal Soder, PhD, GMP Lab Manager, who oversees the GMP facility’s CAR T operations, along with Nathaniel Dudley, PhD, and Drew Schultz. Colin Soder and Thomas Dow provided quality control and assurance for the project. Manufacturing CAR T cells is a complex process requiring 8–10 days of continuous monitoring in specialized bioreactor systems to ensure quality and safety.
The manufacturing of the CAR T cells was a true team effort, strengthened by training support from Nirali N. Shah, MD, Senior Investigator at the National Cancer Institute, whose expertise in CAR T-cell therapy helped establish MSCTC’s GMP protocols, and with important contributions from John Jeppson in Dr. David Akhavan’s lab and the Flow Cytometry Core at KUMC.
A Collaborative Milestone
The Phase I clinical trial (Clinical trials.gov ID: NCT06879340) is led by Joseph McGuirk, DO, Division Director of Hematologic Malignancies and Cellular Therapeutics at KU Cancer Center. Additional contributions from Scott Weir, PharmD, PhD, and the Institute for Advancing Medical Innovation (IAMI) have been critical in guiding regulatory interactions with the FDA, and KCAS Bio is advancing key clinical research studies.
Together, this achievement underscores KU’s growing leadership in cellular therapy innovation, combining in-house manufacturing capacity with clinical expertise to deliver first-in-human trials that could change the standard of care for patients with blood cancers.