FDA Clears Trial for Dual-Targeted CAR T-Cell Cancer Therapy

Food and Drug Administration this week to test genetically engineered CAR T-cell immune cells in adults with advanced colorectal cancer and pediatric patients with solid tumors, according to university announcements. The experimental therapy attacks two specific targets, B7-H3 and IL-8, aiming to overcome the defenses of solid tumors where standard treatments have failed.

University of Colorado Anschutz CAR T-Cell Trial Targets Solid Tumors

The newly approved clinical trial will evaluate an experimental CAR T-cell therapy developed by researchers at CU Anschutz. According to university officials, the treatment will be manufactured at the campus Gates Biomanufacturing Facility. Christopher Lieu, MD, professor of medical oncology and associate director of clinical research at the CU Anschutz Cancer Center, is leading the trial, which is scheduled to begin in December.

The engineered immune cells are designed to seek out and bind to two distinct proteins associated with cancer growth. B7-H3 is a protein found on the surface of most colorectal tumors, while IL-8 promotes tumor growth, inflammation, and cancer spread. By targeting both pathways simultaneously, researchers hope the treatment can breach solid tumor defenses more effectively than traditional chemotherapy.

Did you know? While CAR T-cell therapies have achieved remarkable results in blood cancers like leukemia and lymphoma, applying the same technology to solid tumors has proven significantly more difficult because of the challenge in finding targets that avoid damaging healthy tissue, according to CU Anschutz researchers.

Addressing the Urgent Need for Advanced Colorectal Cancer Treatments

Rates of colorectal cancer among people under 45 have risen substantially over the past several decades, creating an urgent clinical demand for new therapeutic options. When standard therapies stop working, advanced patients face increasingly limited choices, according to Michael Verneris, MD, professor of pediatric oncology at CU Anschutz.

“Given the number of patients we are seeing, we need new approaches,” Lieu stated regarding the pressing need for alternative treatments. Traditional chemotherapy acts broadly on the body, which Lieu likened to dropping an unguided bomb that hits its target while causing substantial collateral damage. In contrast, this immunotherapy trial aims to direct the immune system precisely toward the cancer to generate a much more durable response lasting years rather than months.

Infrastructure and Philanthropic Support Drive Local Innovation

The rapid transition of this therapy from a laboratory concept to a clinical trial highlights the unique layout of CU Anschutz. The campus houses a university, Children’s Hospital Colorado, UCHealth University of Colorado Hospital, and the Gates Biomanufacturing Facility within easy walking distance of one another. Verneris noted that without the Gates Institute’s local manufacturing capabilities, the concept would have remained merely an interesting laboratory idea.

FDA Clears Trial for Dual-Targeted CAR T-Cell Cancer Therapy
Photo: med.stanford.edu

Private philanthropy also played a vital role in funding the path toward human testing. Because clinical trials require substantial financial backing, donor support enabled researchers to move the experimental treatment out of animal models and into patient-facing protocols.

Frequently Asked Questions

What is the primary goal of the CU Anschutz clinical trial?

The trial aims to determine whether the experimental CAR T-cell therapy is safe and can effectively attack advanced colorectal cancer and pediatric solid tumors in humans.

A Phase II trial of zamto-cel, a dual-targeted CAR T-cell product, in the treatment of R/R DLBCL

What are the two targets of the engineered immune cells?

The CAR T-cells simultaneously target B7-H3, a protein found on most colorectal tumors, and IL-8, a protein involved in tumor growth, inflammation, and cancer spread.

Who is eligible for this specific clinical trial?

The trial is open to adults with advanced colorectal cancer and pediatric patients with solid cancers who have already exhausted standard treatment options.


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