Safety assessment of neoantigen peptides-loaded dendritic cell vaccination therapy.

Safety assessment of neoantigen peptides-loaded dendritic cell vaccination therapy. - Vaccination with neoantigen-loaded DCs

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTc030190183

Enrollment

Registered

2020-01-14

Start date

2018-08-06

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant tumor (except leukemia)

Interventions

Vaccination using neoantigen peptides-loaded (autologous) dendritic cells

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Safety	—

Secondary

Measure	Time frame
Efficacy	—

Countries

Japan

Contacts

Public ContactYasunobu Kobayashi

BioThera Clinic

ykobayashi@bio-c.jp+81-3-5919-1762

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026