Phase 1/2 Study of EB-NK-301 (Allogeneic TROP2-CAR NK Cells) in Advanced TROP2-Expressing
study evaluates EB-NK-301, an investigational off-the-shelf allogeneic CAR-NK cell product targeting TROP2, in adults with advanced or metastatic solid tumors that express TROP2 and have progressed after standard therapy. The primary goals are to assess safety and tolerability, identify dose-limiting toxicities (DLTs),
| Condition(s) | Advanced Solid Tumors, Metastatic Solid Tumors, TROP2-Expressing Solid Tumors |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | study evaluates EB-NK-301, an investigational off-the-shelf allogeneic CAR-NK cell product targeting TROP2, in adults with advanced or metastatic solid tumors that express TROP2 and have progressed after standard therapy. The primary goals are to assess safety and tolerability, identify dose-limiting toxicities (DLTs), and determine a recommended Phase 2 dose (RP2D). Secondary goals include preliminary anti-tumor activity, persistence of infused CAR-NK cells, and exploratory immune biomarkers. |
| Who can participate | Inclusion Criteria: * Age 18 to 75 years at the time of informed consent. * Histologically or cytologically confirmed advanced or metastatic solid tumor with documented TROP2 expression (per local testing or central confirmation). * Disease progression on, intolerance to, or ineligibility for available standard therapy. * At least one measurable lesion per RECIST 1.1. * ECOG performance status 0 to 1. * Adequate organ function (hematologic, renal, hepatic) within protocol-defined limits. * Life expectancy ≥ 12 weeks. * Willingness to use effective contraception during study participation and for a protocol-defined period after last infusion (if of childbearing potential). * Ability to understand and willingness to sign written informed consent. Exclusion Criteria: * Active central nervous |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Beijing Biotech |
| Locations | Shenzhen, Guangdong, China |
| Start date | 2026-03-02 |
| NCT ID | NCT07589530 |
| Official listing | https://clinicaltrials.gov/study/NCT07589530 |