Actively Recruiting
Dual-Targeting CAR-NK Cells Targeting Mesothelin (MSLN) and MUC1 in Advanced Pancreatic Ductal Adenocarcinoma
Led by Beijing Biotech · Updated on 2026-03-18
42
Participants Needed
1
Research Sites
125 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Dual-Targeting CAR-NK Cells Targeting Mesothelin (MSLN) and MUC1 in Advanced Pancreatic Ductal Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years at the time of consent.
- Confirmed pancreatic ductal adenocarcinoma (PDAC) by histology or cytology.
- Unresectable locally advanced or metastatic disease with progression after at least one prior standard systemic therapy, or intolerance/ineligibility for standard therapy.
- At least one measurable lesion according to RECIST v1.1.
- Tumor antigen expression by central immunohistochemistry (IHC): either MSLN positive and/or MUC1 positive for Arm A; or CLDN18.2 positive and/or MUC1 positive for Arm B.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Adequate organ function including ANC ≥ 1.0 x 10^9/L; platelets ≥ 75 x 10^9/L; hemoglobin ≥ 8 g/dL; AST/ALT ≤ 3x upper limit normal (ULN) or ≤ 5x ULN with liver metastases; total bilirubin ≤ 1.5x ULN; creatinine clearance ≥ 50 mL/min.
- Life expectancy of at least 12 weeks.
- Negative pregnancy test for individuals of childbearing potential; agreement to use effective contraception during study and follow-up.
- Ability to understand and willingness to sign written informed consent.
You will not qualify if you...
- Active or untreated central nervous system metastases or carcinomatous meningitis.
- Clinically significant uncontrolled infection including bacterial, fungal, or viral infections.
- Known active hepatitis B or C with detectable viral load; uncontrolled HIV infection.
- Prior allogeneic hematopoietic stem cell transplant or solid organ transplant.
- Prior gene-modified cellular therapy (e.g., CAR-T or CAR-NK) within 6 months or prior therapy targeting the same antigen(s).
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China, 518036
Actively Recruiting
Research Team
S
Seni S Lu, Phd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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