Early-Stage Kidney Cancer Trial Aims to Restore Anti-Cancer Immunity
A phase 0 trial is seeking to assess the feasibility of aiding anti-cancer cells with cytokines to restore their function.
CancerNetwork® spoke with Wenxin (Vincent) Xu, MD, a medical oncologist at Dana-Farber Cancer Institute and an assistant professor of medicine at Harvard Medical School, about the rationale for a phase 0 study (NCT06318871) he presented at the 2025 Kidney Cancer Research Summit.1,2
Xu initially explained that patients with metastatic kidney cancers or urothelial bladder cancers may have ineffective natural killer (NK) cells despite preclinical research showing that these cells should be killing cancer cells. He noted that the phase 0 trial is attempting to ascertain why NK cells appear to grow increasingly dysfunctional as kidney tumors increase in size. Furthermore, the trial aims to assess the ability of cytokine-treated anti-cancer cells to attack cancer cells.
He then suggested that the early-stage study is seeking to elucidate the safety and feasibility of the cytokine-based approach; activity in the early-stages of research could help develop further CAR T and CAR NK strategies. Xu concluded in hoping that the findings from the trial will aid in the development of safer, more efficacious, and more accessible therapies.
Transcript
What we know from preclinical research is that natural killer cells are supposed to kill cancer cells. That’s part of their job in the body. Clearly, in patients who have metastatic kidney cancer or urothelial bladder cancer, these cells are somehow not doing their job. We went to ask the question, “Why are these cells not doing their job?” We found that the natural killer cells that infiltrate kidney tumors are increasingly dysfunctional as the tumor grows and are being suppressed in their anti-cancer immunity. This trial is asking the question of whether we can restore the function of these anti-cancer cells by collecting them from patients and treating them with cytokines, hopefully as a new anti-cancer treatment.
It’s an early-stage study; a pilot first-in-human [study]. From this study, we’re hoping to get some science and study how these cells work, to see if they have function, and to figure out if the approach is feasible and safe. The hope is that we’ll see some activity in this early-stage trial, which will let us develop further CAR T and even CAR NK strategies with the hopes that what we learn from this trial will help us make the therapy safer, more efficacious, and more broadly available.
References
- Xu W, Xie W, Liu, F et al. Memory-like natural killer (NK) cell immune therapy in patients with renal cell carcinoma or urothelial carcinoma (NCT06318871). Presented at: 2025 Kidney Cancer Research Summit; July 17-18, 2025. Boston, Massachusetts.
- Memory-like natural killer (NK) cell therapy in patients with renal cell carcinoma or urothelial carcinoma. ClinicalTrials.gov. Updated June 11, 2025. Accessed July 22, 2025. https://tinyurl.com/44scjkfe
![“The trial will be successful, or [we’ll] declare it a success if we see at least 3 of 24 responses overall,” stated Ravi, MD, BChir, MRCP, on the phase 2 LASER trial in RCC.](/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fcancernetwork%2F9addaac21d809a7b642a567b0a704cbb15d87ac5-2966x1684.png%3Ffit%3Dcrop%26auto%3Dformat&w=3840&q=30 "“The trial will be successful, or [we’ll] declare it a success if we see at least 3 of 24 responses overall,” stated Ravi, MD, BChir, MRCP, on the phase 2 LASER trial in RCC.")
