An Open-Label Phase 1/2 Study of EBNK-001, an Allogeneic Natural Killer (NK) Cell Therapy Administered After Cyclophosphamide/Fludarabine Lymphodepletion With Low-Dose Interleukin-15, With or Without Pembrolizumab, in Participants With Advanced Solid Tumors
This Phase 1/2 study evaluates the safety, tolerability, and preliminary anti-tumor activity of EBNK-001 (allogeneic NK cells) given after lymphodepleting cyclophosphamide/fludarabine (CY/FLU) and supported with low-dose IL-15, administered either alone or in combination with pembrolizumab in adults with advanced/metastatic solid tumors. The study will determine a recommended Phase 2 dose (RP2D) and explore signals of clinical activity using RECIST-based response criteria.
• Age ≥18 years.
• Histologically confirmed advanced/metastatic solid tumor that is relapsed/refractory after standard therapy (or no standard therapy available).
• Measurable disease per RECIST v1.1 (or iRECIST if applicable).
• ECOG performance status 0-1 (or 0-2 as allowed).
• Adequate organ function (thresholds modeled on NK protocols):
• Platelets ≥ 75,000/µL; hemoglobin ≥ 9 g/dL; ANC ≥ 1,000/µL (unsupported by growth factors/transfusions as defined).
• eGFR ≥ 60 mL/min/1.73m².
• AST/ALT ≤ 3× ULN.
• Oxygen saturation ≥ 90% on room air (with PFT requirements if indicated).
• LVEF ≥ 40% (by ECHO/MUGA/CMR).
• If brain metastases are present, they must be stable for a defined period (example: ≥3 months) and not requiring escalating steroids.