Two presentations at the Society for Immunotherapy of Cancer (SITC) Annual Meeting highlight promising new clinical trial results
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, announced findings from two HPV-related studies that highlight the potential of novel T cell therapies to achieve long-lasting remission and complete tumor regression in patients with advanced epithelial cancers. Christian Hinrichs, MD, Co-Director of the Duncan and Nancy MacMillan Cancer Immunology and Metabolism Center of Excellence at Rutgers Cancer Institute and Chief of the Section of Cancer Immunotherapy, led the studies and presented these findings at the Society for Immunotherapy of Cancer (SITC) Annual Meeting, in National Harbor, Maryland, November 5-9, 2025.
In one study, researchers reported encouraging interim results from a Phase II clinical trial evaluating genetically engineered T cell receptor (TCR)-T cells designed to target the HPV16 E7 oncoprotein (E7 T cells) in patients with metastatic HPV-associated cancers. The treatment consisted of 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 that are generally regarded as incurable and for which there are limited treatment options. Five had head and neck cancer, two had cervical cancer, two had anal cancer, and one had esophageal cancer. The treatment was generally well tolerated, with side effects consistent with the preparative regimen and aldesleukin. Six out of 10 patients achieved substantial tumor shrinkage, including two patients who experienced complete tumor regression that remains ongoing at 11 and 12 months, respectively. Both of these patients had previously received immunotherapy and other standard therapeutic options.
"Metastatic HPV-associated cancers remain difficult to treat," said Dr. Hinrichs. "We found that E7-directed T cells can induce meaningful, and sometimes complete, responses in patients with limited options. It's an encouraging step toward effective engineered T cell therapies for these and other epithelial cancers."
We found that E7-directed T cells can induce meaningful, and sometimes complete, responses in patients with limited options. It's an encouraging step toward effective engineered T cell therapies for these and other epithelial cancers.
Christian Hinrichs
Co-Director, Duncan and Nancy MacMillan Cancer Immunology and Metabolism Center of Excellence at Rutgers Cancer Institute and Ch
Development of this treatment has been through a collaboration between the National Cancer Institute and Rutgers Cancer Institute, with the phase II study conducted at Rutgers Cancer Institute. The cell products for the study were manufactured in a Good Manufacturing Practices (GMP) facility on-site at Rutgers Cancer Institute, a part of the Duncan and Nancy MacMillan Cancer Immunology and Metabolism Center of Excellence. The Center is uniquely positioned to advance the development of novel cell therapies through its specialized research capabilities and GMP infrastructure, supporting both innovative clinical trials and the translation of laboratory discoveries into patient care.
"When I finished my treatment, I couldn't believe how quickly I started feeling better," said Maria, a patient from Philadelphia. "Within a month, the nodules were gone, and for the first time in years, I felt free, full of energy and living the life. I can spend time with my son, do the things I love, and really enjoy life again. I'm so grateful to the team that made this possible and proud to be living proof of the difference their research can make."
In a second study, investigators reported the extraordinary finding that two patients with metastatic cervical cancer remain in complete remission 10 years after receiving a single infusion of tumor-infiltrating lymphocyte (TIL) therapy. Conducted as part of clinical trial NCT01585428, the study represents 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 exhibited no evidence of disease based on imaging and circulating tumor DNA analysis. 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.
"Findings like these highlight the importance of conducting research at an NCI-designated Comprehensive Cancer Center such as Rutgers Cancer Institute said Steven K. Libutti, MD, FACS, William N. Hait Director, Rutgers Cancer Institute and Senior Vice President, Oncology Services, RWJBarnabas Health. "Centers like ours, the only one in New Jersey, bring together the scientific expertise, clinical resources and collaborative environment needed to translate new discoveries from the laboratory into clinical trials, and ultimately into meaningful treatments for patients."
When I finished my treatment, I couldn't believe how quickly I started feeling better. Within a month, the nodules were gone, and for the first time in years, I felt free, full of energy and living the life.
Maria
Patient
One patient who has had an ongoing complete response is Sue of Washington, DC. "Participating in this clinical trial felt like a calling. When I joined the study, my cancer was very advanced, and I wanted to use whatever time I had left to help enhance 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 the scans," said Sue. "Now, 12 years later, I'm still cancer-free and deeply grateful to the doctors and researchers who made that possible. It's an incredible and unexpected blessing to see how my participation has led to new discoveries that have the potential to help other patients in the future."
"These studies indicate that one-time cell therapies can achieve durable responses in epithelial cancers, which historically have been more resistant to these treatments than blood cancers," said Dr. Hinrichs. "The decade-long complete responses to TIL therapy give hope that these patients may be cured. The E7 T cell results that include complete responses are encouraging and support continued study of the approach."
