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

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to induce a peptide-specific immune response in CLL patients by multi-peptide vaccination with a patient-individualized peptide cocktail.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Tuebingen
• Collaborators: Katharinenhospital Stuttgart; Klinikum Stuttgart; Marienhospital Stuttgart; Robert Bosch Gesellschaft für Medizinische Forschung mbH
• Treatments: Imiquimod; Lenalidomide; Thalidomide; Vaccines

Criteria

1. Documented diagnosis of CLL/SLL according to IWCLL guidelines.

For Screening phase:

• No pretreatment of CLL/SLL

• Ability to mount an immune response: Positive immunresponse to EBV/CMV peptide mix (analyzed in 12 day recall IFNγ ELISPOT).

For Vaccination phase:

• Achievement of response (at least PR according to IWCLL guidelines) after first-line therapy according to treating physicians choice.

2. HLA typing positive for HLA alleles of peptides included in the warehouse with proven immunogenicity: HLA-A*01, A*02, A*03, A*24, B*07, B*08.

3. Ability to understand and voluntarily sign an informed consent form.

4. Age ≥ 18 years at the time of signing the informed consent form.

5. Ability to adhere to the study visit schedule and other protocol requirements.

6. Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2.

7. Negative serological Hepatitis B and C test or negative PCR in case of positive serological test without evidence of an active infection, negative HIV test within 6 weeks prior to randomization.