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RECRUITING
NCT07510828
PHASE1/PHASE2

PRISM-NK: Precision-Matched Allogeneic Single- or Dual-Target CAR-NK Cells for Advanced Solid Tumors

Sponsor: Beijing Biotech

View on ClinicalTrials.gov

Summary

This Phase 1/2, open-label, biomarker-guided platform study evaluates the safety, tolerability, and preliminary anti-tumor activity of banked allogeneic donor-derived chimeric antigen receptor natural killer (CAR-NK) cells in adults with advanced solid tumors. During screening, tumor antigen profiling is performed using tissue biopsy and/or liquid biopsy (circulating tumor DNA and/or circulating tumor cells). Participants are assigned to receive either a single-target CAR-NK product (matched to the dominant tumor antigen) or a dual-target CAR-NK product (matched to two co-expressed antigens) to reduce the risk of antigen escape.

Official title: A Phase 1/2 Biomarker-Guided Platform Study of Allogeneic Donor-Derived Single-Target or Dual-Target CAR-NK Cell Therapy Selected by Tumor Antigen Profiling (Liquid Biopsy and/or Tissue Biopsy) in Participants With Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-03-02

Completion Date

2028-04-17

Last Updated

2026-04-06

Healthy Volunteers

No

Interventions

BIOLOGICAL

EB-PT-CAR-NK-S

single-target CAR-NK cell infusion, IV

BIOLOGICAL

EB-PT-CAR-NK-D

dual-target CAR-NK cell infusion, IV

DRUG

Lymphodepleting chemotherapy

fludarabine + cyclophosphamide

DRUG

Cytokine support

low-dose IL-2 or IL-15 agonist

Locations (1)

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China