iVAC-CLL01: Patient-individualized Peptide Vaccination After First Line Therapy of CLL

PHASE2CompletedINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

October 5, 2016

Primary Completion Date

September 30, 2022

Study Completion Date

November 18, 2022

Conditions
Leukemia, Chronic Lymphatic
Interventions
BIOLOGICAL

Peptide Vaccine

Individualized multi-peptide cocktail consisting of 300 μg each of 5 HLA class I and 4 HLA class II restricted peptides. The peptides for each individual patient will be selected from a warehouse consisting of 30 different peptides restricted by the 6 most common HLA class I allotypes (A\*01, A\*02, A\*03, A\*24, B\*07, B\*08) and 4 HLA class II peptides. Peptides will be administered subcutaneously. Vaccination will take place on d1, d4, d8, d15, d22 followed by vaccinations every 4 weeks for 1 year. The peptide warehouse is selected based on our data on the non-mutant HLA-presented antigenome of CLL identified as frequently presented CLL-associated T cell epitopes with a high potential for broad clinical application.

DRUG

Imiquimod

All patients will receive imiquimod (Aldara®) as local adjuvant, applied topically at the side of vaccination 18h to 24h prior to the vaccination.

Trial Locations (5)

70174

Katharinenhospital, Stuttgart

70176

Diakonie-Klinikum Stuttagrt, Stuttgart

70199

Marienhospital, Stuttgart

70376

Robert-Bosch-Krankenhaus Abteilung fuer Haematologie, Onkologie und Palliativmedizin, Stuttgart

72076

University Hospital Tuebingen, Tübingen

All Listed Sponsors
collaborator

Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)

OTHER

collaborator

Klinikum Stuttgart

OTHER

collaborator

Marienhospital Stuttgart

OTHER

collaborator

Katharinenhospital Stuttgart

UNKNOWN

lead

University Hospital Tuebingen

OTHER

NCT02802943 - iVAC-CLL01: Patient-individualized Peptide Vaccination After First Line Therapy of CLL | Biotech Hunter | Biotech Hunter