RecruitingPhase 1Phase 2NCT07480928

Dual-Targeting CAR-NK Cells Targeting Mesothelin (MSLN) and MUC1 in Advanced Pancreatic Ductal Adenocarcinoma

A Phase 1/2, Open-label, Biomarker-guided, Dose-escalation and Expansion Study of Dual-targeting CAR-NK Cells Directed Against Mesothelin (MSLN) and MUC1, With an Exploratory CLDN18.2/MUC1 Dual-target Cohort, in Patients With Unresectable or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)


Sponsor

Beijing Biotech

Enrollment

42 participants

Start Date

Feb 2, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This example study evaluates the safety, tolerability, and preliminary anti-tumor activity of investigational, dual-targeting chimeric antigen receptor natural killer (CAR-NK) cell products for patients with advanced pancreatic ductal adenocarcinoma (PDAC). Participants are assigned to one of two biomarker-defined cohorts based on tumor antigen expression: (A) Mesothelin (MSLN) and/or MUC1, or (B) Claudin 18.2 (CLDN18.2) and/or MUC1. The study uses a dose-escalation followed by dose-expansion design to define a recommended Phase 2 dose (RP2D) and to estimate response rates in each cohort.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of cancer treatment for advanced pancreatic cancer using specially engineered immune cells called CAR-NK cells. These cells are designed to recognize and attack cancer cells by targeting specific proteins on their surface. This is an early-phase study to see whether the treatment is safe and shows signs of working. **You may be eligible if...** - You are aged 18–75 and have been diagnosed with pancreatic ductal adenocarcinoma (a specific type of pancreatic cancer) - Your cancer cannot be surgically removed and has progressed despite at least one previous treatment - Your tumor tests positive for certain proteins (MSLN, MUC1, or CLDN18.2) that the therapy targets - You are in good enough physical condition to participate (ECOG 0–1) - You have adequate blood counts, liver, and kidney function - Your life expectancy is at least 12 weeks **You may NOT be eligible if...** - Your cancer has spread to the brain - You have an active, uncontrolled infection including HIV, hepatitis B, or hepatitis C - You have had an organ or stem cell transplant - You received a similar gene-modified cell therapy within the past 6 months 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-DNK101 dual-targeting CAR-NK cells (MSLN + MUC1)

Allogeneic CAR-NK cells engineered with a dual-recognition CAR targeting MSLN and MUC1. Administered as an IV infusion on Day 0 (dose level dependent).

BIOLOGICALEB-DNK102 dual-targeting CAR-NK cells (CLDN18.2 + MUC1)

Allogeneic CAR-NK cells engineered with a dual-recognition CAR targeting CLDN18.2 and MUC1. Administered as an IV infusion on Day 0 (dose level dependent)

DRUGLymphodepleting chemotherapy (Flu/Cy)

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


Locations(1)

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

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NCT07480928


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