Neo-antigen cancer vaccination using antigen-presenting cells (Neo-antigen cancer vaccination)

Completed

• Conditions: Cancer, sarcoma

• Registration Number: jRCTc040210109

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-02
• Study Start: 2022-03-24
• Last Update Posted: 2024-11-26

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

1. Age at the time of informed consent: 20 to 75 years old
2. Performance status: 0/1
3. Pathological diagnosis as a tyep of cancer or sarcoma
4. Adjuvant therapy during the course of standard therapies
5. Already determined neo-antigens (Genetic mutation) under the cancer genomic diagnosis
6. Neither cardiovascular diseases nor respiratory disorders that would prevent blood apheresis
7. No organ function abnormalities, no blood abnormalities, no bleeding tendency
8. No infectious diseases
9. Understand the risk and benefit of the dendritic cell-vaccination
10. No other clinical trials

Exclusion Criteria

1. Application of molecular target medicine based on cancer genomic diagnosis
2. Allergy to penicillin or OK-432
3. Advanced diseases such as obstructive jaundice and involvement either in pleura or in peritoneum
4. Requiring platelet or red blood cell transfusion or albumin infusion
5. Disseminated intravascular coagulation syndrome and deep vein thrombosis
6. An infectious disease such as viral hepatitis (following the standard of the Japanese Red Cross Blood Center)
7. History of cerebrovascular disorders such as cerebral hemorrhage and infarction
8. Poor control of lung diseases such as chronic obstructive lung disease, bronchial asthma, and requiring oxygen dosage
9. Pneumonitis (the past)
10. Autoimmune diseases (present or the past)
11. Steroid hormone therapy continuously administered for diseases other than the prevention of temporal chemotherapeutic drug allergy
12. Mental disease (including neurosis, the panic disorder)
13. The past of epilepsy having poor control
14. Difficulty in arm vessel blood access for apheresis
15. No informed consent due to cancer
16. Inability to understand the risk and benefit of the DC vaccination
17. Pregnant or nursing women, desire to bear children
18. Under the treatment with immune checkpoint inhibitors during this clinical trial
19. Under the radiotherapy during this clinical trial
20. Physician judgment that a patient is inappropriate for treatment

Study & Design

• Study Type: Interventional
• Study Design: single assignment

Primary Outcome Measures

Name	Time	Method
-		Safety (adverse reactions, severe adverse events)

Secondary Outcome Measures

Name	Time	Method
Immune monitoring of the biomarkers		ELISpot assays, T cell markers