Neoantigen-specific dendritic cell vaccines against recurrent solid cancers

JRCT ID: jRCTc040240165

Registered date:14/01/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Recurrent solid cancers
• Date of first enrollment: 14/01/2025
• Target sample size: 10
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Neoantigen-specific dendritic cell (DC) vaccines therapy (phase Ia) is going to be perform ed against recurrent solid cancers harboring accordant neoantigen mutation and HLA-typing.

Outcome(s)

Primary Outcome

Completion rate of dendritic cell vaccines
More than 4-time dendritic cell vaccines during 2 months after the onset of vaccination is rated as completion.

Secondary Outcome

1.Immunological response (skin test, CTL as say)
2.Response rate
3.Relapse-free survival
4.Overall survival

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Histological diagnosis of cancers
2.Cancer patients who are enrolled in HOPE project
3.Cancer patients who are subjected to clinical sequencing
4.Postoperative patients whose genetic profiling is accordant with neoantigen mutant peptides and HLA-typing list
5.Advanced(metastatic)or relapsed cancers after the standard therapy regimens
Advanced (metastatic) cancer patients who rejected the standard therapy
6.Over 20 years old
7.Performance status 0-2
8.Measurable lesions by imaging diagnosis
9.No severe organ dysfunction
10.No severe hemostatic disorders
11.Expecting diagnosis with more than 3 months
12.Over 2week interval after the previous treatment
13.Informed consents obtained

Exclude criteria

1.Within 14 days after the last cancer treatment
2.Severe systemic infection, hemostatic dysfunction and organ disorders
3.Systemic administration of steroids or immunosuppressant drugs
4.Pregnant women
5.Hypersensitivity to dendritic cell vaccines
6.Severe immunological disorders (autoimmune disease, immunosuppression)
7.Multiple cancers
8. Any of syphilis, hepatitis B, hepatitis C,HTLV-1 and HIV-1 infection is detected
9. Excluded patients according to the decision by medical doctors

Related Information

• Primary Sponsor: Akiyama Yasuto