This Phase 1/2, open-label, biomarker-guided platform study evaluates the safety, tolerability, and preliminary anti-tumor activity of banked allogeneic donor-derived chimeric antigen receptor natural killer (CAR-NK) cells in adults with advanced solid tumors. During screening, tumor antigen profiling is performed using tissue biopsy and/or liquid biopsy (circulating tumor DNA and/or circulating tumor cells).
Participants are assigned to receive either a single-target CAR-NK product (matched to the dominant tumor antigen) or a dual-target CAR-NK product (matched to two co-expressed antigens) to reduce the risk of antigen escape.
Age 18 to 75 years at the time of consent.
Histologically or cytologically confirmed advanced or metastatic solid tumor that is refractory to, relapsed after, or intolerant of standard therapy, or for which no standard therapy exists.
At least 1 measurable lesion per RECIST v1.1.
Tumor antigen positivity documented by tissue biopsy and/or liquid biopsy using a protocol-specified assay; for dual-target cohort: co-expression of both antigens above threshold.
Active, uncontrolled infection, including uncontrolled bacterial, fungal, or viral infection.
Known uncontrolled HIV infection; active hepatitis B or hepatitis C with evidence of active replication (per local testing).
Clinically significant cardiovascular disease (e.g., recent myocardial infarction, uncontrolled arrhythmia) that would increase risk from lymphodepletion or infusion.
Active central nervous system (CNS) metastases that are symptomatic or require escalating steroids.
Sequential
EB-PT-CAR-NK-S
Biological/Vaccinesingle-target CAR-NK cell infusion, IV
EB-PT-CAR-NK-D
Biological/Vaccinedual-target CAR-NK cell infusion, IV
Lymphodepleting chemotherapy
Drugfludarabine + cyclophosphamide
Cytokine support
Druglow-dose IL-2 or IL-15 agonist
Dose- limiting toxicities
Dose limiting toxicities refer to specific adverse events or side effects that prevent further dose escalation of an investigational drug or therapy in a clinical trial. DLTs are pre-defined based on severity, duration, and impact on patient safety, typically graded according to established criteria such as the Common Terminology Criteria for Adverse Events (CTCAE). Monitoring DLTs is a critical outcome measure in early-phase (Phase I/II) studies, as it helps determine the maximum tolerated dose (MTD) and guides safe dosing for subsequent trial phases.
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