Researchers from Rutgers Cancer Institute, New Jersey's only National Cancer Institute (NCI)-designated Comprehensive Cancer Center, and RWJBarnabas Health, along with colleagues from the National Cancer Institute, a center of the National Institutes of Health, have made groundbreaking discoveries in the field of HPV-related cancers. Their studies demonstrate the potential of novel T cell therapies to achieve long-term remission and complete tumor regression in patients with advanced epithelial cancers. Led by Dr. Christian Hinrichs, the research team presented their findings at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in November 2025.
In one study, the researchers reported promising interim results from a Phase II clinical trial. This trial evaluated genetically engineered T cell receptor (TCR)-T cells designed to target the HPV16 E7 oncoprotein in patients with metastatic HPV-associated cancers. The treatment involved a conditioning regimen, a single infusion of up to 50 billion E7 T cells, and a median of three doses of adjuvant aldesleukin. All 10 patients had advanced cancers with limited treatment options. Encouragingly, six out of 10 patients experienced substantial tumor shrinkage, including two patients who achieved complete tumor regression, which has persisted for over a year. These patients had previously received immunotherapy and other standard treatments.
Dr. Hinrichs emphasized the significance of these findings, stating, 'Metastatic HPV-associated cancers remain challenging to treat. However, our study demonstrates that E7-directed T cells can induce meaningful and sometimes complete responses in patients with limited treatment options. This is a significant step towards effective engineered T cell therapies for these and other epithelial cancers.'
The development of this treatment was a collaborative effort between the National Cancer Institute and Rutgers Cancer Institute. The phase II study was conducted at Rutgers Cancer Institute, where the cell products were manufactured in a Good Manufacturing Practices (GMP) facility within the Duncan and Nancy MacMillan Cancer Immunology and Metabolism Center of Excellence. This center is uniquely equipped to advance novel cell therapies through its specialized research capabilities and GMP infrastructure, facilitating both clinical trials and the translation of laboratory discoveries into patient care.
One patient, Maria from Philadelphia, shared her remarkable experience: 'After completing my treatment, I was amazed at how quickly I felt better. Within a month, the nodules disappeared, and I felt free, full of energy, and living life to the fullest. I can spend time with my son, do the things I love, and truly enjoy life again. I am incredibly grateful to the team that made this possible and proud to be living proof of the impact their research can have.'
In a second study, investigators made an extraordinary discovery. Two patients with metastatic cervical cancer remained in complete remission 10 years after receiving a single infusion of tumor-infiltrating lymphocyte (TIL) therapy. This study, part of clinical trial NCT01585428, provides the strongest evidence to date that cellular therapy can produce long-term, potentially curative responses in epithelial cancers, the most common type of malignancy. A decade after treatment, patients showed no evidence of disease based on imaging and circulating tumor DNA analysis. The administered anti-tumor T cells underwent a temporary expansion phase that coincided with tumor shrinkage and apparent elimination. Tumor responses have continued long after the T cell responses, suggesting that the tumors were cleared during the initial response.
Steven K. Libutti, MD, FACS, William N. Hait Director, and Senior Vice President, Oncology Services at RWJBarnabas Health, highlighted the importance of conducting research at an NCI-designated Comprehensive Cancer Center like Rutgers Cancer Institute. He stated, 'Centers like ours, the only one in New Jersey, bring together scientific expertise, clinical resources, and a collaborative environment to translate new discoveries from the laboratory into clinical trials and ultimately into meaningful treatments for patients.'
Sue, a patient from Washington, DC, who has had an ongoing complete response, shared her experience: 'Participating in this clinical trial felt like a calling. When I joined the study, my cancer was very advanced, and I wanted to contribute to research that could benefit others. I never imagined the treatment would work for me, but just two months after receiving my TIL infusion, my cancer was undetectable on scans. Now, 12 years later, I'm still cancer-free and deeply grateful to the doctors and researchers who made it possible. It's an incredible and unexpected blessing to see how my participation has led to new discoveries that could help other patients in the future.'
Dr. Hinrichs concluded, 'These studies indicate that one-time cell therapies can achieve durable responses in epithelial cancers, which have historically been more resistant to these treatments than blood cancers. The decade-long complete responses to TIL therapy offer hope that these patients may be cured. The E7 T cell results, including complete responses, are encouraging and support further study of this approach.'
