Phase 1/2 Study of EB-NK-301 (Allogeneic TROP2-CAR NK Cells) in Advanced TROP2-Expressing Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
EB-NK-301: Investigational allogeneic CAR-NK cell product targeting TROP2, administered by intravenous infusion.
Fludarabine: Lymphodepleting chemotherapy administered prior to EB-NK-301 infusion to facilitate immune cell engraftment and persistence.
Study 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.
Eligibility
Primary outcome measure(s)
- Incidence of dose-limiting toxicities (DLTs) (CTCAE v5.0) — 28 days
- Incidence and severity of treatment-emergent adverse events (AEs) — 12 months
- Recommended Phase 2 dose (RP2D) of EB-NK-301 — 6 months
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Peking University Shenzhen Hospital | Shenzhen | Guangdong | Recruiting |
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07589530 on ClinicalTrials.gov ↗ ← All trials in China