A Phase 1/2, Open-Label, Biomarker-Driven Study of Allogeneic Donor-Derived CAR-NK Cells With Antigen Selection by Tissue Biopsy and/or Liquid Biopsy Profiling in Participants With Relapsed/Refractory Advanced Solid Tumors (Single-Target vs Dual-Target Strategy)
This Phase 1/2 study evaluates the safety, feasibility, and preliminary anti-tumor activity of allogeneic donor-derived CAR-NK cells in participants with advanced solid tumors. The CAR target antigen is selected for each participant after tumor profiling using a tissue biopsy and/or liquid biopsy. Participants will receive either a single-target or dual-target CAR-NK product based on the antigen profile.
• Age 18-75 years.
• Histologically or cytologically confirmed advanced/unresectable or metastatic solid tumor that is relapsed/refractory after standard therapy, or no standard therapy available.
• Targetable antigen positivity from the protocol target menu based on:
⁃ tissue biopsy and/or liquid biopsy platform (as defined in the lab manual).
• Arm assignment rules :
• Arm A: ≥1 antigen meets positive threshold
• Arm B: ≥2 antigens meet positive threshold
• ECOG performance status 0-1 (or 0-2 ).
• At least one measurable lesion by RECIST 1.1.
• Adequate organ function (hematologic, renal, hepatic, cardiac) within protocol-defined limits.
• Willingness to undergo blood draws and required biopsies (when medically feasible).
• Negative pregnancy test for participants of childbearing potential; agreement to effective contraception during and after study treatment.