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

JRCT ID: jRCTc030210068

Registered date:07/05/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: wet age-related macular degeneration
• Date of first enrollment: 25/11/2021
• Target sample size: 10
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

<WT1 peptide pulsed dendritic cell vaccine>
Approximately 10,000,000 WT1 peptide pulsed dendritic cell vaccines are injected intradermally or subcutaneously at a total of 4 sites on either the extensor surfaces of both upper arms~axillae or the anterior surfaces of both thighs. The vaccine may be continued once every 2 weeks unless skip criteria are met. However, the maximum number of doses is 15.

<Aflibercept>
(1) Dosing Criteria
Aflibercept (genetical recombination) 2 mg (0.05 mL) should be administered intravenously once every month for 3 consecutive induction cycles.
(2) Additional dosage standard
During the treatment period of WT1 peptide-pulsed dendritic cell vaccine, aflibercept intravitreal administration should be started as a fixed dose every 3 months after the 3rd dose (16 weeks after starting treatment), 7th dose (24 weeks after starting treatment), 11th dose (32 weeks after starting treatment), and post-observation period if the following findings are observed.

Translated with www.DeepL.com/Translator (free version)
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 Outcome: Safety(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: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Gunji Hisato