Phase 1 Study of NEUK203-13 Cell Therapy for Safety and Early Effectiveness in Adults with Advanced Small Cell Lung Cancer or Neuroendocrine Tumors Who Have Not Responded to Previous Treatments

What this Trial Is About

Researchers are evaluating a novel cell therapy called NEUK203-13 Injection for patients with advanced small cell lung cancer SCLC or late stage neuroendocrine tumors NETs who have not responded to previous treatments. This Phase I trial aims to assess the safety and tolerability of this new therapy while also observing its potential to control tumor growth. NEUK203-13 is an off-the-shelf CAR-NK cell therapy targeting the DLL3 protein, which is highly expressed in these cancers. The treatment includes three doses of NEUK203-13 given by intravenous infusion on days 1, 4, and 7 after a lymphodepletion chemotherapy regimen with cyclophosphamide and fludarabine to prepare the body. Supportive medication with interleukin-2 IL-2 is given on days 1, 4, 7, and 10 to help maintain the infused cells. The trial plans to enroll 7 to 9 patients and includes two preset dose levels. This therapy uses engineered NK cells derived from induced pluripotent stem cells, designed to better survive and attack cancer cells. Participants will be closely monitored for side effects, including risks specific to cell therapies like Cytokine Release Syndrome and immune-related neurotoxicity. Assessments will include measuring the presence of NEUK203-13 cells in blood, tumor response based on DLL3 expression, and overall disease control. Safety will be tracked for 12 months, with periodic evaluations to observe treatment effects and pharmacokinetics. The total study duration extends up to 12 months to gather comprehensive safety and preliminary efficacy data.

Safety, Tolerability and Preliminary Efficacy of NEUK203-13 in Refractory Neuroendocrine Tumor Patients