Study of Neoantigen mRNA Vaccines in Patients With Resectable Pancreatic Cancer

Sponsor
Jinling Hospital, China
Study ID
NCT06326736
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Surgery — PROCEDURE
    Tumors of patients with pancreatic cancer must be radiographically resectable, and subjects with histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1) will be selected for neoantigen vaccine creation.
  • Camrelizumab — DRUG
    Camrelizumab will be administered 6 weeks post-tumor resection.
  • SJ-Neo006 — BIOLOGICAL
    SJ-Neo006 will be prepared as personalized tumor Vaccines and administered 9 weeks post-tumor resection (+/- 2 weeks).
  • Gemcitabine+Abraxane — DRUG
    Gemcitabine+Abraxane regimen will be administered 21 weeks post-tumor resection.

Study Details

The purpose of this study is to evaluate the safety and efficacy of treating pancreatic cancer with surgery to remove cancerour tissue, followed by camrelizumab and a personalized cancer mRNA vaccines.

Key Dates

Start date
Apr 30, 2024
Status verified
Mar 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pancreatic Cancer
    Resectable primary pancreatic tumor

Primary Outcome Measure

Incidence of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: 2 years ]

Central Contacts

Related Studies