Multi-peptide Vaccination and Bispecific PSMAxCD3 Antibody Treatment in Patients With Prostate Cancer
Sponsor: University Hospital Tuebingen • ClinicalTrials.gov ID: NCT07860047
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This trial is a phase II, randomized, open label study designed to evaluate safety, tolerability and efficacy of CC-1, a bispecific antibody (bsAb) with PSMAxCD3 specificity, and of VACXS15-PC01, a prostate cancer (PC)-specific multi-peptide vaccine, both administered as single agent or in combination to patients affected with biochemical recurrence (BCR) of PC after local therapy with curative intent. Patients will not receive other treatments during trial participation.
Interventions
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PSMAxCD3, bispecific antibody CC-1
(Drug)
CC-1 is applied subcutaneously once per week for 12 weeks in Arm 2. Due to priming doses up to 14 applications are planned.
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Multipeptide Vaccine VAC-XS15-PC01
(Drug)
The vaccine VAC-XS15-PC01 consists of 300 µg of each of 10 PC-associated peptides. The vaccine cocktail (final volume 500 µL) will be administered subcutaneously (SC), adjuvanted with the TLR1/2 ligand XS15 (50 µg) and emulsified in Montanide ISA 51 VG at a 1:1 ratio. A total of three vaccinations are planned in Arm 1, administered 4 weeks apart from each other.
Eligibility criteria
Conditions
Locations
- NCT Studienzentrale; Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg — Heidelberg, Baden-Wurttemberg, Germany
- CCU Transltional Immunolgy, University Hospital Tübingen — Tübingen, Baden-Wurttemberg, Germany
- Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin - Studienzentrale Onkologie — Berlin, Beriln, Germany
- Universitätsklinikum Essen, Abteilung Urologie — Essen, North Rhine-Westphalia, Germany
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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