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

NCT07410494 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2026-02-18

No results posted yet for this study

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.

Conditions

  • Cancer
  • Breast Cancer
  • Non-Small Cell Lung Cancer (NSCLC)
  • Colorectal Cancer (Locally Advanced or Metastatic)
  • Prostate Cancer - Recurrent
  • Pancreatic Ductal Adenocarcinoma (PDAC)
  • Ovarian Cancer
  • Glioblastoma
  • Melanoma (Skin Cancer)
  • Acute Myeloid Leukemia (AML)
  • Non Hodgkin Lymphoma
  • Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma
  • Liver Cancer

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.

Sponsors & Collaborators

  • Essen Biotech

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2027-12-28
Completion
2028-12-28

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07410494 on ClinicalTrials.gov