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

ConditionsPancreatic Ductal Adenocarcinoma (PDAC)Unresectable Locally AdvancedMetastatic Disease
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • EB-DNK101 dual-targeting CAR-NK cells (MSLN + MUC1)

    Biological/Vaccine

    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).

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

    Biological/Vaccine

    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).

  • Lymphodepleting chemotherapy (Flu/Cy)

    Drug

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

Treatment groups

42 Participants
are divided into 2 treatment groups
Group A: Arm A: EB-DNK101 (MSLN/MUC1 Dual-CAR NK)Experimental treatment 3 interventions
Group B: Arm B: EB-DNK102 (CLDN18.2/MUC1 Dual-CAR NK)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Incidence of dose-limiting toxicities (DLTs)

Time frame
28 Days
2

Incidence and severity of treatment-emergent adverse events (TEAEs)

Time frame
12 months
3

Maximum tolerated dose (MTD)

Time frame
12 months

Secondary outcomes

1

Objective response rate (ORR) per RECIST v1.1

Time frame
12 months
2

Disease control rate (DCR)

Time frame
12 months
3

Duration of response (DOR)

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Biotech

Lead sponsor

Source ClinicalTrials.gov
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