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

NCT04335890 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2026-03-04

No results posted yet for this study

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).

Conditions

  • Melanoma, Uveal Metastatic

Interventions

BIOLOGICAL

Vaccination with IKKb matured Dendritic Cells

IKKb matured autologous monocyte derived dendritic cells loaded with RNAs; intravenous Infusion with a dose escalation starting with 7.5 mio Dendritic Cells for the first vaccination up to 30 mio cells per vaccination

Sponsors & Collaborators

  • Hasumi International Research Foundation

    lead OTHER

Principal Investigators

  • Beatrice Schuler-Thurner, MD · University Hospital Erlangen, Germany

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-24
Primary Completion
2022-09-20
Completion
2024-11-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04335890 on ClinicalTrials.gov