Dual-Target CAR-NK Cells Targeting Mesothelin (MSLN) and MUC1 in Advanced Pancreatic Ductal Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing Biotech
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- EB-DNK101 dual-targeting CAR-NK cells (MSLN + MUC1)
- EB-DNK102 dual-targeting CAR-NK cells (CLDN18.2 + MUC1)
- Lymphodepleting chemotherapy (Flu/Cy)
Treatment groups
42 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov