Dual-Target CAR-NK Cells for Advanced Breast Cancer (HER2+ and TNBC)
Condition(s) studied
Investigational drug(s) / intervention(s)
Dual-target CAR-NK cells (EB-DT-CAR-NK): Route: IV infusion. Schedule: single infusion on Day 0; optional second infusion on Day 7 in the absence of dose-limiting toxicity (DLT) and with adequate clinical status.
Lymphodepleting chemotherapy: fludarabine (Days -5 to -3) and cyclophosphamide (Days -5 to -4), prior to CAR-NK infusion.
Supportive care: Premedication per institutional standard (e.g., acetaminophen and antihistamine). Tumor lysis and infection prophylaxis per institutional guidelines.
Study summary
This study tests the safety and preliminary anti-tumor activity of an investigational dual-target chimeric antigen receptor natural killer (CAR-NK) cell therapy in adults with advanced breast cancer. After a tumor antigen assessment (HER2/ERBB2, MUC1, ROR1, and in some TNBC cases mesothelin), each participant will receive the most suitable dual-target CAR-NK product for their tumor profile, following short-course lymphodepleting chemotherapy.
Eligibility
Primary outcome measure(s)
- Incidence of dose-limiting toxicities (DLTs) — 28 Days
Incidence of dose-limiting toxicities (DLTs) (including cytokine release syndrome and neurotoxicity) graded by CTCAE v5.0 and ASTCT consensus criteria for CRS/ICANS - Safety profile — 12 months
Safety profile by type, frequency, severity, and relatedness of treatment-emergent adverse events (AEs) and serious AEs. - Recommended Phase 2 Dose — 56 days
Recommended Phase 2 Dose (RP2D) based on DLTs, overall safety, and biologic activity (CAR-NK expansion/persistence).
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Peking University Shenzhen Hospital | Shenzhen | Guangdong | Recruiting |
More Beijing Biotech trials in China
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 NCT07486089 on ClinicalTrials.gov ↗ ← All trials in China