Aurora, Colorado, U.S., September 10, 2026
University of Colorado Anschutz Medical Campus (CU Anschutz) has received U.S. Food and Drug Administration (FDA) clearance to begin a clinical trial evaluating an experimental CAR T-cell therapy for adults with advanced colorectal cancer and pediatric patients with solid tumors who have exhausted standard treatment options. Developed by researchers at CU Anschutz, the investigational therapy is designed to target B7-H3 and IL-8, two biological pathways associated with tumor growth, inflammation and cancer spread. The trial is expected to begin in December 2026 and will initially focus on determining whether the genetically engineered immune cells are safe and capable of attacking tumors in patients.
CU Anschutz Advances Dual-Target CAR T Therapy
The investigational therapy represents a dual-target CAR T-cell approach designed to address some of the major challenges associated with using cellular immunotherapy against solid tumors. CAR T-cell therapy involves collecting a patient’s own T cells, genetically modifying them to recognize specific cancer-associated targets, expanding the engineered cells in large numbers and returning them to the patient to seek and destroy cancer cells. While CAR T-cell therapies have produced significant responses in certain blood cancers, their development for solid tumors such as colorectal cancer has been considerably more challenging. Researchers at CU Anschutz selected B7-H3 as one of the targets because the protein is found on many colorectal tumors. The therapy also targets IL-8, a signaling molecule involved in tumor growth, inflammation and cancer progression. By simultaneously addressing these two pathways, investigators hope to improve the ability of engineered T cells to recognize cancer and overcome biological defenses within the solid tumor microenvironment. The strategy is intended to provide a more targeted immune-based treatment approach than conventional therapies. However, the investigational therapy has only demonstrated effectiveness in animal models to date, and the upcoming clinical trial will determine whether the preclinical findings can translate into meaningful responses and an acceptable safety profile in humans.
B7-H3 and IL-8 Provide Dual Cancer Targets
A central challenge in developing CAR T-cell therapy for solid tumors is identifying targets that are sufficiently abundant on cancer cells while being limited on healthy tissues. B7-H3 is considered an attractive target because it is present across a substantial proportion of colorectal cancers, potentially allowing the therapy to address a broader patient population than immunotherapies requiring more narrowly defined tumor biomarkers. The addition of IL-8 targeting is intended to provide a second mechanism for addressing the tumor environment. IL-8 contributes to processes associated with tumor growth and spread and may help create conditions that allow cancer cells to evade immune attack. The researchers believe targeting both B7-H3 and the IL-8 pathway could give engineered immune cells a greater opportunity to penetrate and attack solid tumors. The approach could eventually have applications beyond colorectal cancer if clinical development demonstrates safety and therapeutic activity. According to CU Anschutz, the biological pathways being targeted may also be relevant to certain breast, lung and ovarian cancers, although these potential applications would require separate evaluation.
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FDA-Cleared Trial Moves Therapy Toward Patients
The FDA clearance enables investigators to transition the CU Anschutz CAR T-cell program from laboratory development into clinical testing. The trial will be led by Christopher Lieu, MD, professor of medical oncology at CU Anschutz and associate director of clinical research at the CU Anschutz Cancer Center. Michael Verneris, MD, professor of pediatric oncology and co-leader of Tumor-Host Interactions at the CU Anschutz Cancer Center, is among the researchers involved in developing the approach. The engineered cells will be manufactured at the campus’s Gates Biomanufacturing Facility, creating an integrated pathway from research and cell engineering through manufacturing and clinical testing. CU Anschutz brings together the university, cancer center, Children’s Hospital Colorado, UCHealth University of Colorado Hospital and the manufacturing facility in a closely connected research and clinical environment.
The initial clinical evaluation will focus on safety and the ability of the CAR T cells to attack cancer. This is an important first step because the therapy remains investigational and its clinical efficacy has not yet been established. If the approach demonstrates a favorable safety profile and evidence of antitumor activity, further studies could evaluate its potential in larger patient populations and additional solid tumors. The FDA clearance therefore represents an important milestone in the development of next-generation CAR T-cell therapy for colorectal cancer, while the forthcoming trial will determine whether the dual-target strategy can overcome some of the biological barriers that have limited cellular immunotherapy in solid tumors.
Source: CU Anschutz press release
