NK Cells + N-803 for Kidney and Bladder Cancer

This trial tests a new approach to treating advanced kidney and bladder cancer. It combines special immune cells called CIML NK cells (Cytokine Induced Memory-like Natural Killer Cells) with a low dose of IL-2, a protein that boosts the immune system. Researchers aim to determine if this combination is safe and effective for individuals whose cancer has progressed despite previous treatments. This trial suits those with clear cell renal cell carcinoma or urothelial carcinoma who have experienced treatment failures with prior standard therapies. As an Early Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

The trial protocol does not specify if you must stop taking your current medications. However, you cannot have had anti-tumor chemotherapy or investigational agents within 2 weeks prior to enrollment, or immunotherapy within 4 weeks prior. Also, you cannot be on systemic corticosteroid therapy at a dose of 10 mg or more of prednisone (or equivalent) for at least 2 weeks before enrolling.

Research has shown that a new type of immune cell, called cytokine-induced memory-like (CIML) natural killer (NK) cells, is safe in early trials. These cells are designed to attack cancer cells and have been well-tolerated in initial studies, with few serious side effects reported.

Trials have demonstrated that N-803, a drug that boosts the immune system, is generally safe with mild side effects. Specifically, studies with bladder cancer patients found N-803 to have low toxicity and did not cause strong immune reactions.

Researchers are excited about using Cytokine Induced Memory-like Natural Killer (CIML NK) Cells combined with N-803 for treating kidney and bladder cancer because this approach leverages the body's own immune cells to fight cancer more effectively. Unlike standard treatments like surgery, chemotherapy, or radiation, which can be broadly toxic, CIML NK cells are designed to specifically target and destroy cancer cells while minimizing harm to healthy cells. Additionally, N-803 acts as an immune booster, enhancing the effectiveness of these NK cells. This innovative combination not only aims to improve patient outcomes by precisely targeting cancer cells but also holds potential for fewer side effects compared to traditional therapies.

Research has shown that a special type of immune cell, called CIML NK cells, may help treat various cancers. These cells enhance the body's ability to fight cancer. Early results from similar treatments have demonstrated promising effects against tumors, suggesting potential benefits for patients with advanced cancers. In this trial, participants will receive CIML NK cells combined with low-dose IL-2 to determine the maximum tolerated dose.