IKKb-matured RNA-loaded Dendritic Cells for Metastasised Uveal Melanoma

  • STATUS
    Recruiting
  • End date
    Jun 30, 2025
  • participants needed
    12
  • sponsor
    Hasumi International Research Foundation
Updated on 12 November 2020
Investigator
Schuler-Thurner Beatrice, MD
Primary Contact
University Hospital Erlangen Dept. of Dermatology (8.7 mi away) Contact

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 with autologous tumor-RNA + RNA coding for defined antigens and driver mutations will be added to a standard therapy chosen by the tumor board (either checkpoint blockade or chemotherapy).

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 patients will receive reduced doses for the first 4 vaccinations, namely 7.5 mio (1st and 2nd vaccination) and 15 mio (3rd and 4th vaccination) DC followed by the full dose of 30 mio for subsequent vaccinations. Patients number 5 to 8 will receive initially reduced doses of 15 mio (1st and 2nd vaccination) DC for the first 2 vaccinations, and the full dose of 30 mio for subsequent vaccinations. Patients number 8 to 12 will receive the full dose of 30 mio cells from vaccination 1 onwards provided that no major side effects occurred. Patients will be vaccinated in a staggered approach by selectively decelerating release of the vaccine.

DCIKKb = autologous, monocyte-derived DC that are matured with the standard cocktail (TNF-alpha, IL-1 beta, IL-6 and PGE2) and IKKb-RNA loaded by electroporation with 1) autologous PCR-amplified total tumor mRNA, 2) RNA coding for defined tumor associated antigens (TAA) namely gp100, tyrosinase, PRAME, MAGE-A3, IDO) and 3) RNA coding for driver mutations (GNAQ/GNA11Q209 or R183, or the less frequently occurring SF3B1R625, CYSLTR2L129Q or PLCB4D630) by electroporation; RNAs for selected TAAs are in stock and will be transfected into the DCs only if expressed in the individual tumor of a patient (shown by RNA sequencing of the tumor); RNAs for selected driver mutations are in stock and will be loaded into the DCs only if the respective mutation is found (proven by exome and RNA sequencing) in the individual tumor.

Details
Treatment Vaccination with IKKb matured Dendritic Cells
Clinical Study IdentifierNCT04335890
SponsorHasumi International Research Foundation
Last Modified on12 November 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 75 yrs?
Gender: Male or Female
Do you have Melanoma, Uveal Metastatic?
Do you have any of these conditions: Do you have Melanoma, Uveal Metastatic??
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 Criteria

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
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