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RECRUITING
NCT07589530
PHASE1/PHASE2

Phase 1/2 Study of EB-NK-301 (Allogeneic TROP2-CAR NK Cells) in Advanced TROP2-Expressing Solid Tumors

Sponsor: Beijing Biotech

View on ClinicalTrials.gov

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.

Official title: A Phase 1/2, Open-Label, Dose-Escalation and Dose-Expansion Study Evaluating the Safety, Tolerability, and Preliminary Anti-tumor Activity of EB-NK-301 (Allogeneic TROP2-Targeted CAR NK Cells) Following Lymphodepleting Chemotherapy in Adults With Advanced or Metastatic TROP2-Expressing Solid Tumors

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-03-02

Completion Date

2028-03-17

Last Updated

2026-05-15

Healthy Volunteers

No

Interventions

BIOLOGICAL

EB-NK-301

Investigational allogeneic CAR-NK cell product targeting TROP2, administered by intravenous infusion.

DRUG

Fludarabine

Lymphodepleting chemotherapy administered prior to EB-NK-301 infusion to facilitate immune cell engraftment and persistence.

Locations (1)

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China