DC vaccine with neoantigen for malignant tumor.

Phase 1

Recruiting

• Conditions: malignant tumor

• Registration Number: JPRN-jRCTc030190182
• Lead Sponsor: Takimoto Rishu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-10
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

(1)Be diagnosed with malignant tumor by imaging findings or pathological or cytological study.
(2)Have a successful genetic analysis of tumor sample tested by one of the clinical laboratories assigned by at Seta Clinic Tokyo.
(3)Have an Eastern Cooperative Oncology Group performance-status score of 0 or 1.
(4)Visit outpatient department on schedule.
(5)Have an adequate function of liver, kidney, and bone marrow when the eligibility is confirmed.
(6)Provide written consent to participate this study.

Exclusion Criteria

(1)Be apparent from the clinical manifestation of pulmonary fibrosis or interstitial pneumonia.
(2)Have a history of a serious drug allergy.
(3)Have a positive result of HIV antibody.
(4)Have a serious cardiac disorder.
(5)Have an active autoimmune disorder.
(6)Have a concurrent cancer.
(7)Have an infectious disorder that is difficult to control.
(8)Be a female who is pregnant, lactating, or with a possibility of pregnancy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy

Secondary Outcome Measures

Name	Time	Method
Safety, Immunological response