NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTc030210068

Registered date:07/05/2021

WT1 peptide-pulsed dendritic cell therapy for wet age-related macular degeneration

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedwet age-related macular degeneration
Date of first enrollment07/05/2021
Target sample size10
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)<WT1 peptide-pulsed dendritic cell > Approximately 10,000,000 WT1 peptide-pulsed dendritic cell vaccines are injected intradermally or subcutaneously into either the extensor side of both upper arms to the axilla or the anterior surface of both thighs at a time. Unless the following skip criteria are met, the 1st to 6th doses can be continued once every 2 weeks. From the 7th dose, the dose can be continued once every 4 weeks. However, the maximum dose is 15 times. <Aflibercept> (1) Administration criteria Intravitreal administration of 2 mg (0.05 mL) of aflibercept (genetical recombination) is performed once a month and three times in a row (introduction phase). (2) Additional administration criteria WT1 Peptide Pulse Dendritic Cell Vaccine During the treatment period, the following findings were observed during the 7th administration (26 weeks after the start of treatment), the 10th administration (38 weeks after the start of treatment), the 13th administration (50 weeks after the start of treatment), and the follow-up period. If is observed, intravitreal administration of aflibercept should be started with fixed administration every 3 months. 1)Central retinal thickness (CRT) increases by 100 micrometes or more from the minimum value 2)New CNV appears 3)New macular hemorrhage appears

Outcome(s)

Primary OutcomeSafety(Adverse event rate,Rate of serious adverse events)
Secondary Outcome(1) Average change in best-corrected visual acuity from post-treatment (baseline) (2) Amount of change in central retinal thickness (3) Amount of change in lesion area of choroidal neovascularization (4) Delayed hypersensitivity reaction to WT1 peptide (5) WT1-specific immunological monitoring (6) WT1 non-specific immune response

Key inclusion & exclusion criteria

Age minimum>= 50age old
Age maximum<= 80age old
GenderBoth
Include criteria1) Clinically diagnosed with wet age-related macular degeneration 2) The name of the disease in 1) has been announced. 3) HLA type is HLA-A (A * 2402, A * 0201, A * 0206), HLA-DR (DRB1 * 0101, DRB1 * 0405, DRB1 * 0802, DRB1 * 0803, DRB1 * 0901, DRB1 * 1201, DRB1 * 1403, DRB1 * 1501, DRB1 * 1502, DRB5 * 0102), HLA-DP (DPB1 * 0201, DPB1 * 0202, DPB1 * 0402, DPB1 * 0501, DPB1 * 0901), HLA-DQ (DQB1 * 0301, One of DQB1 * 0302, DQB1 * 0401, DQB1 * 0501, DQB1 * 0601, DQB1 * 0602. 4) Outpatient visits are possible according to the research implementation schedule. 5) Patient without treatment for cancer. 6) 50 to 80 years old 7) Patients who retain the functions of major organs (confirmed by pre-registration examination). 8) Written consent from the patient has been obtained for participation in this study. 9) Meet the apheresis eligibility criteria for dendritic cell production
Exclude criteria1) Have an uncontrolled infectious disease 2) Serious complications: malignant hypertension, severe congestive heart failure, severe coronary failure, unstable edema or myocardial infarction within 12 months, severe arrhythmia requiring medication and more than 2nd degree Patients with conduction abnormalities such as AV block, liver cirrhosis, uncontrolled diabetes, pulmonary fibrosis, interstitial pneumonia, marked peripheral edema, etc. active infections, active hepatitis B 3) Patients who are considered unsuitable for participation in this clinical trial due to complications or whose safety may be compromised due to serious medical events. 4) Cases in which antitumor treatment such as chemotherapy / radiochemotherapy was performed within 1 year 5) Have serious complications 6) Patients with myelodysplastic syndrome, myelodysplastic / myeloproliferative disorders and chronic myelogenous leukemia 7) History of severe drug hypersensitivity (excluding iodine contrast media) 8) Patients with severe mental illness 9) Patients with autoimmune disease 10) Patients with a history of allergies to OK-432 and penicillin G 11) Pregnant or lactating women 12) Pregnant women who are not willing to contracept

Related Information

Contact

Public contact
Name Masaki Nakamura
Address 163-1 Kashiwashita,Kasiwa-shi,Chiba-ken Chiba Japan 277-8567
Telephone +81-4-7164-1111
E-mail h20ms.loveinthisclub@gmail.com
Affiliation The Jikei University Kashiwa Hospital
Scientific contact
Name Hisato Gunji
Address 163-1 Kashiwashita,Kasiwa-shi,Chiba-ken Chiba Japan 277-8567
Telephone +81-4-7164-1111
E-mail hg6727@jikei.ac.jp
Affiliation The Jikei University Kashiwa Hospital