Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07486089
PHASE1/PHASE2

Dual-Target CAR-NK Cells for Advanced Breast Cancer (HER2+ and TNBC)

Sponsor: Beijing Biotech

View on ClinicalTrials.gov

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.

Official title: Phase 1/2, Biomarker-guided, Open-label Study of Allogeneic Dual-target CAR-NK Cells Directed Against HER2/ERBB2, MUC1, and/or ROR1 in Patients With Advanced or Metastatic Breast Cancer (Including HER2-positive and Triple-negative Disease).

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-02-02

Completion Date

2028-03-17

Last Updated

2026-03-20

Healthy Volunteers

No

Interventions

BIOLOGICAL

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.

DRUG

Lymphodepleting chemotherapy

fludarabine (Days -5 to -3) and cyclophosphamide (Days -5 to -4), prior to CAR-NK infusion.

OTHER

Supportive care

Premedication per institutional standard (e.g., acetaminophen and antihistamine). Tumor lysis and infection prophylaxis per institutional guidelines.

Locations (1)

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China