RecruitingPhase 1Phase 2NCT07410494

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

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)


Sponsor

Essen Biotech

Enrollment

85 participants

Start Date

Feb 1, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 8 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study tests a cutting-edge type of cancer immunotherapy using NK cells (natural killer cells — a type of immune cell) that have been genetically engineered to seek out and destroy cancer cells. The cells are matched to each patient based on what proteins their tumor expresses. **You may be eligible if...** - You are 18 to 75 years old - You have a confirmed advanced or metastatic solid tumor that has come back or stopped responding to standard treatment, or no standard treatment is available - Your tumor tests positive for at least one (or two, for the dual-target arm) specific surface proteins that the CAR-NK cells can target - Your overall health is good (ECOG 0-2) - You have at least one measurable tumor on imaging - Your blood counts and organ function are adequate **You may NOT be eligible if...** - You have previously received CAR-T or CAR-NK cell therapy too recently - You have an active uncontrolled infection, uncontrolled HIV, or active hepatitis B/C - You have active brain metastases requiring increasing steroids - You have active autoimmune disease on systemic immune suppression - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALEB-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.

BIOLOGICALDual-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

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NCT07410494


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