Phase 12 Study of Donor-Derived CAR-NK Cell Therapy Guided by Tumor Biomarkers for Advanced Solid Tumors Using Single or Dual Target Approach

What this Trial Is About

Researchers are evaluating the safety, feasibility, and early anti-tumor effects of allogeneic donor-derived CAR-NK cells in people with advanced solid tumors that have returned or do not respond to standard treatments. The study uses a biomarker-driven approach, where tumor profiling through tissue or liquid biopsy helps select the target antigen or antigens for each participants treatment. This open-label Phase 12 trial compares single-target and dual-target CAR-NK cell therapies based on the tumor antigen profile. Participants undergo tumor antigen profiling to determine eligibility and whether they receive a single-target or dual-target CAR-NK cell product. CAR-NK cells are collected from healthy donors, genetically modified to express one or two chimeric antigen receptors, and given after lymphodepleting chemotherapy with drugs like fludarabine and cyclophosphamide. Optional low-dose interleukin-2 may be given to support the CAR-NK cells. The study includes arms for single-target and dual-target antigen therapies based on the participants tumor profile. During the study, participants have safety monitored intensively for 28 days after treatment. Tumor imaging and correlative studies, including CAR-NK cell persistence and circulating tumor DNA levels, are performed at scheduled times. Researchers track adverse events and dose-limiting toxicities in the first month and evaluate tumor response and disease control over 12 months. Participants will also undergo blood draws and biopsies as needed. The total study duration varies by participant and includes follow-up assessments to understand treatment effects and safety.

Biomarker-Guided Allogeneic Single-Target or Dual-Target CAR-NK Cell Therapy for Advanced Solid Tumors