Safety assessment of neoantigen peptides-loaded dendritic cell vaccination therapy.
- Conditions
- Malignant tumor (except leukemia)
- Registration Number
- JPRN-jRCTc030190183
- Lead Sponsor
- Tanigawa Keishi
- Brief Summary
eoantigen DCs would be a safe treatment method. Neoantigen DCs would induce the acquisition of immune reaction against neoantigens.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 20
A patient must:
- have ECOG Performance Status of 0, 1 and 2.
- maintain adequate function of key organs when the eligibility is confirmed, in particular:
1. haemoglobin 8.0 g/dl or more
2. platelet 50.000 /mm3 or more
3. total bilirubin 3 x ULN or more
4. AST/ALT 3 x ULN or less
5. creatinine 3 x ULN or less
- provide written consent for genetic analysis of tumor sample; neoantigen-screening analysis, and for treatment of those neoantigens-loaded DC vaccination.
- have a proper mental condition and an ability to recognize the object and contents of the study when informed consent is obtained.
A patient must not:
- be impossible to obtain blood sample by Leukapeheresis.
- be positive in HIV antibody test.
- have active auto-immune disorder.
- have serious underlying disease.
- be pregnant (including pregnancy seeker)
- be judged ineligibles by clinician in this trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method