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Starting soon Phase 1/2

Personalized Tumor Neoantigen MRNA Therapy for Advanced Pancreatic Cancer.

NCT06888648 · tracked via the Priya Life Science China tracker
Phase
Phase 1/2
Started
2025-04-01
Last updated
2025-03-21

Condition(s) studied

Pancreatic Cancer MetastaticPancreatic Cancer Non-resectable

Investigational drug(s) / intervention(s)

individualized anti-tumor new antigen iNeo-Vac-R01 injectionmFOLFIRINOX Treatment RegimenSintilimab injection →

individualized anti-tumor new antigen iNeo-Vac-R01 injection: The individualized anti-tumor new antigen iNeo-Vac-R01 injection was commissioned by Hangzhou Nuanjin Biotechnology Co., Ltd., and all patients were admitted into the therapeutic intervention group. According to the results of previous non-clinical studies, the individualized mRNA injection of 100 μ g was a tolerable dose.

mFOLFIRINOX Treatment Regimen: continuous intravenous infusion of fluorouracil 2400mg / m², for 46 hours, leucovorin 400mg / m², irinotecan 135mg / m², and oxaliplatin 68mg / m², every 2 weeks

Sintilimab injection: Sintilimab Injection, 200mg, intravenous infusion, every 3 weeks

Study summary

This study is a single-arm phase I/II clinical study to evaluate the effectiveness of evaluate the feasibility and safety of personalized tumor neoantigen mRNA therapy (iNeo-Vac-R01) in combination with PD-1 antibody and standard chemotherapy regimens for the treatment of patients with advanced pancreatic cancer.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: (1) Subjects who meet all the following entry criteria enter the pre-screening phase of the study: 1. Voluntary signing of the informed consent form; 2. Age: 18 and 75 years old, male or female; 3. Evaluation as metastatic pancreatic cancer or postoperative recurrence according to the 2024 NCCN guidelines; 4. No systemic treatment, or disease progression with gemcitabine-based first-line chemotherapy. 5. An Eastern Cooperative Oncology Group (ECOG) physical fitness status score of 0 or 1; 6. According to the efficacy evaluation criteria for solid tumors (RECIST 1.1); 7. Can obtain sufficient fresh tumor tissue samples for exome and transcriptome sequencing analysis; 8. Main organ function of heart, liver and kidney is normal: 9. Ferproductive men and women of childbearing age agree to take effective contraception from the date to the last dose of test drug; women of childbearing age included premenopause and women within 2 years after menopause; 10. Ability to follow the study protocol and follow-up procedures. (2) Subjects who meet all the following enrollment criteria enter the formal screening stage of the study and enter the study medication process: 1. Voluntary signing of the informed consent form; 2. Age: 18 and 75 years old, male or female; 3. Pancreatic ductal adenocarcinoma (PDAC) diagnosed by pathology (histology or cytology); 4. No systemic treatment or gemcitabine-based first-line chemotherapy. 5. An Eastern Cooperative Oncology Group (ECOG) physical fitness status score of 0 or 1; 6. Main organ function of heart, liver and kidney is normal: 7. Ferproductive men and women of childbearing age agree to take effective contraception from the date to the last dose of test drug; women of childbearing age include premenopause and women within 2 years after menopause; 8. Ability to follow the study protocol and follow-up procedures. Exclusion Criteria: Subjects will be excluded from this study if they meet any of the following criteria: 1. Pancreatic cancer has central nervous system metastasis or meningeal metastasis; 2. At the same time with other malignant tumors, but cured basal cell cancer, thyroid cancer, cervical dysplasia, etc., have been in the disease for more than 5 years or do not considered to be easy to relapse except; 3. History of bone marrow transplantation, allogeneic organ transplantation, or allogeneic hematopoietic stem cell transplantation; 4. Patients with immunosuppressants, that is, those who require regular use of immunosuppressants 4 weeks before the screening period and the clinical study, including but not limited to the following conditions: severe asthma, autoimmune diseases or immune deficiency, treated with immunosuppressive drugs, and known history of primary immunodeficiency; except type 1 diabetes, autoimmune-related hypothyroidism requiring hormone therapy, vitiligo and psoriasis that do not require systemic therapy; 5. Active bacterial or fungal infection identified by clinical diagnosis; a history of active TB or tuberculosis; 6. Patients with positive human immunodeficiency virus (HIV) antibody, positive treponema pallidum for syphilis (TP) antibody, active hepatitis C (positive hepatitis C virus (HCV) antibody and positive HCV RNA result), active hepatitis B; 7. Herpesvirus infection (except those who scab for more than 4 weeks); respiratory virus infection (except those who have recovered for more than 4 weeks); 8. Uncontrolled complications include but are not limited to active infection, symptomatic congestive heart failure, unstable angina, arrhythmia; severe coronary artery disease or cerebrovascular disease, or other diseases considered unacceptable by the investigator; 9. Previous history of drug abuse, clinical or psychological or social factors affecting informed consent or study implementation; a history of mental illness; 10. Patients with a history of food, drug or vaccine allergy or other potential immunotherapy allergies as considered by the Investigator. 11. Women born during pregnancy or lactation; 12. The investigator is not fit for enrollment or may not complete the trial for other reasons.

Primary outcome measure(s)

  • Occurence and frequence of AE and SAE — Up to 2 years
    Occurence and frequence of Adverse Event (AE) and Serious Adverse Event (SAE) (NCI CTCAE 5.0)

Trial sites (1)

FacilityCityRegionStatus
First Affiliated Hospital of Zhejiang University Schlool of Medicine Hangzhou Zhejiang
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06888648 on ClinicalTrials.gov ↗ ← All trials in China