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RECRUITING
NCT07410494
PHASE1/PHASE2

Biomarker-Guided Allogeneic Single-Target or Dual-Target CAR-NK Cell Therapy for Advanced Solid Tumors

Sponsor: Essen Biotech

View on ClinicalTrials.gov

Summary

This Phase 1/2 study evaluates the safety, feasibility, and preliminary anti-tumor activity of allogeneic donor-derived CAR-NK cells in participants with advanced solid tumors. The CAR target antigen is selected for each participant after tumor profiling using a tissue biopsy and/or liquid biopsy. Participants will receive either a single-target or dual-target CAR-NK product based on the antigen profile.

Official title: A Phase 1/2, Open-Label, Biomarker-Driven Study of Allogeneic Donor-Derived CAR-NK Cells With Antigen Selection by Tissue Biopsy and/or Liquid Biopsy Profiling in Participants With Relapsed/Refractory Advanced Solid Tumors (Single-Target vs Dual-Target Strategy)

Key Details

Gender

All

Age Range

8 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

85

Start Date

2026-02-01

Completion Date

2028-12-28

Last Updated

2026-02-18

Healthy Volunteers

No

Interventions

BIOLOGICAL

EB-SELECT Single-Target CAR-NK Cells

Donor-derived CAR-NK cells expressing a single CAR selected from the target menu. WITH Fludarabine (IV) + Cyclophosphamide (IV), administered prior to CAR-NK infusion. Similar conditioning drugs are used in CAR-NK solid tumor trials.

BIOLOGICAL

Dual-Target Antigen-Selected CAR-NK

Participants whose profiling identifies two actionable antigens, or strong evidence of antigen heterogeneity. WITH Fludarabine (IV) + Cyclophosphamide (IV), administered prior to CAR-NK infusion . Similar conditioning drugs are used in CAR-NK solid tumor trials.

Locations (1)

District One Hospital

Beijing, Beijing Municipality, China