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

Phase 1

Recruiting

• Conditions: wet age-related macular degeneration

• Registration Number: JPRN-jRCTc030210068
• Lead Sponsor: Gunji Hisato

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-07
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1) 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) Over 50 years of age
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

Exclusion Criteria

1) 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety(Adverse event rate,Rate of serious adverse events)

Secondary Outcome Measures

Name	Time	Method
(1) Average change in best-corrected visual acuity from post-treatment (baseline)<br>(2) Amount of change in central retinal thickness<br>(3) Amount of change in lesion area of choroidal neovascularization<br>(4) Delayed hypersensitivity reaction to WT1 peptide<br>(5) WT1-specific immunological monitoring<br>(6) WT1 non-specific immune response