Dual-target CAR-NK cells targeting MSLN + MUC1 or CLDN18.2 + MUC1 in advanced PDAC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 1/2 trial using two allogeneic CAR-NK cell products that target different tumor antigens. Participants are assigned to Arm A (MSLN and/or MUC1) or Arm B (CLDN18.2 and/or MUC1) based on tumor antigen expression, with a dose-escalation followed by expansion to determine a recommended Phase 2 dose. Lymphodepleting chemotherapy is given before CAR-NK infusion, and up to three infusions may be given if toxicity is manageable and disease is stable. Safety monitoring focuses on cytokine release syndrome, neurotoxicity, infusion reactions, and other adverse events, while efficacy is assessed by tumor response. Eligibility requires unresectable or metastatic PDAC after prior therapy, measurable disease, and antigen positivity.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18 to 75 years at the time of consent.
* Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC).
* Unresectable locally advanced or metastatic disease with progression after at least 1 prior standard systemic therapy regimen, or intolerance/ineligibility for standard therapy.
* At least 1 measurable lesion per RECIST v1.1.
* Tumor antigen expression by central IHC (archival or fresh biopsy): • Arm A eligibility: MSLN positive and/or MUC1 positive. • Arm B eligibility: CLDN18.2 positive and/or MUC1 positive. (Example threshold: IHC 2+ or 3+ staining in \>=50% of tumor cells, or H-score above protocol-defined cutoff.)
* ECOG performance status 0-1.
* Adequate organ function (example): ANC \>= 1.0 x 10\^9/L; platelets \>= 75 x 10\^9/L; hemoglobin \>= 8 g/dL; AST/ALT \<= 3x ULN (\<= 5x ULN with liver metastases); total bilirubin \<= 1.5x ULN; creatinine clearance \>= 50 mL/min.
* Life expectancy \>= 12 weeks.
* Negative pregnancy test for individuals of childbearing potential; agreement to use effective contraception during study participation and for a protocol-defined follow-up period.
* Ability to understand and willingness to sign written informed consent.

Exclusion Criteria:

* Active or untreated CNS metastases or carcinomatous meningitis.
* Clinically significant uncontrolled infection (including uncontrolled bacterial, fungal, or viral infection).
* Known active hepatitis B or hepatitis C with detectable viral load; known uncontrolled HIV infection.
* Prior allogeneic hematopoietic stem cell transplant or solid organ transplant.
* Prior gene-modified cellular therapy (e.g., CAR-T/CAR-NK) within 6 months or prior therapy targeting the same antigen(s) Ongoing requirement for systemic immunosuppressive therapy (e.g., chronic corticosteroids above physiologic replacement).
* Clinically significant cardiovascular disease (e.g., recent myocardial infarction, uncontrolled arrhythmia, or NYHA class III/IV heart failure) within a protocol-defined period.
* Active autoimmune disease requiring systemic treatment in the past 2 years (replacement therapy allowed).
* Pregnant or breastfeeding.
* Any medical, psychiatric, or social condition that, in the investigator's opinion, would interfere with safe participation or interpretation of results.

Where it's running

• Peking University Shenzhen Hospital
  Shenzhen, Guangdong, China Recruiting

Study contacts

• Study coordinator: Seni S Lu, Phd
• Email: Seni-Lu@beijing-biotech.com
• Phone: +86 13076790030

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.