Status:
UNKNOWN
IKKb-matured, RNA-loaded Dendritic Cells for Metastasised Uveal Melanoma
Lead Sponsor:
Hasumi International Research Foundation
Conditions:
Melanoma, Uveal Metastatic
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
A Phase I vaccination trial in patients suffering from recently diagnosed metastatic uveal melanoma not cureable with local therapy and needing systemic therapy. IKKb-matured Dendritic Cells loaded wi...
Detailed Description
Intravenous infusion of 7.5 to 30 mio DCIKKb at 9 vaccination time points (week 1, 3, 7, 13, 19, 25, 31, 37 and 42) and in intervals of 2, 4, and 6 intervals of 6 weeks) is scheduled; the first 4 pati...
Eligibility Criteria
Inclusion
- Histologically confirmed unresectable stage IV metastatic uveal melanoma as per AJCC staging system 2014, 7th edition (updated 2018) not curable with local therapy modalities
- WHO performance status of 0, 1 or 2
- age from 18 and ≤ 75 years
- negative pregnancy test
- signed informed consent
Exclusion
- Major serious illness
- evidence for HIV-1, HIV-2, HTLV-1, HBV or HCV infection
- active autoimmune disease requiring immunosuppressive therapy
- splenectomy or radiation therapy of the spleen
- organ allografts
- pregnancy
- lactation
- psychiatric disorders
- severe organic brain syndrome
Key Trial Info
Start Date :
June 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2024
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04335890
Start Date
June 24 2020
End Date
January 30 2024
Last Update
March 17 2022
Active Locations (1)
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1
University Hospital Erlangen Dept. of Dermatology
Erlangen, Bavaria, Germany, 91054