Multi-peptide Vaccination and PSMAxCD3 Antibody Therapy for Prostate Cancer with Biochemical Recurrence

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, open-label phase II study evaluating safety, tolerability, and preliminary efficacy of CC-1, a PSMAxCD3 bispecific antibody, and VAC-XS15-PC01, a 10-epitope multi-peptide vaccine, as single agents or in combination in men with biochemical recurrence after definitive local treatment. The trial has three arms: VAC-XS15-PC01 alone, CC-1 alone, and CC-1 plus VAC-XS15-PC01, with up to 84 participants (28 per arm). A translational program will monitor PSA dynamics and immune responses to detect early signals of efficacy while assessing safety and tolerability of the therapies, alone and in combination. Enrollment is randomized 1:1:1 with an anticipated 15% dropout. The study includes translational endpoints and immunogenicity analyses to understand response patterns.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Understand and voluntarily sign an IC document prior to any study related assessments/procedures

  * Understand and voluntarily sign an IC document prior to any study related assessments/procedures
  * Patient is able to understand and comply with the protocol for the duration of the study including treatment and scheduled visits and examinations
  * Men aged ≥ 18 and ≤80 years
  * Histologic diagnosis of prostatic adenocarcinoma
  * Biochemical recurrence (BCR): PSA recurrence after treatment with curative intent; PSA ≥0.2 ng/mL or PSA \> nadir + 2 ng/mL (after definitive RT), with two increasing PSA values prior to study treatment; AND no distant metastasis upon PSMA-PET imaging
  * Patients are ineligible to receive available treatment alternatives
  * Low risk of rapid disease progression, defined as:

    o PSA-DT \> 1 year AND pathological ISUP grade \< 4 for men with prior RP OR Interval to BCR \> 18 months AND biopsy ISUP grade \< 4 for men with prior radiation therapy
  * In case of second relapse PSA-DT \> 9 months
  * Eastern Cooperative Oncology Group (ECOG) performance status ≤1

Exclusion Criteria:

* • PSA \>5 ng/mL (at screening)

  * Patients who are receiving or have previously received androgen deprivation treatment.

Except testosterone has recovered to normal levels: patients who have previously received anti-hormonal treatment testosterone must be \>12 nmol/l.

* Patients who are planned to or are undergoing salvage therapy (e.g. radiation)
* Clinically significant xerostomia (dry mouth \>1grade according to CTCAE v6.0)
* Untreated current or prior distant metastasis of PC
* Other malignancy within the last 2 years except: adequately treated non-melanoma skin cancer and non-muscle invasive bladder cancer.
* Concurrent or previous treatment within 30 days in another interventional clinical trial with an investigational anti-cancer therapy
* Clinical signs of active infection (\> grade 2 according to CTCAE v6.0)
* History of HIV infection
* Viral active or chronic hepatitis (HBV or HCV)
* Autoimmune disease that requires or has required treatment with systemic immunosuppressive treatments, except low dose corticosteroids (\< 10 mg/ day), in the past 1 year
* Ongoing relevant CNS pathology (e.g. seizure, paresis, aphasia, cerebrovascular ischemia, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder)
* Epilepsy requiring pharmacologic treatment
* Major surgery within 4 weeks of starting study treatment. Patients must have recovered from any effects of major surgery.
* Heart failure NYHA III/IV
* Severe obstructive or restrictive ventilation disorder
* Known intolerance to CC-1, or other immunoglobulin drug products as well as hypersensitivity to any of the excipients present in the respective drug products (CC-1, VAC-XS15-PC01)
* Refrain from blood donation during the course of the study
* Male patients have to refrain from sperm donations for 6 months after last IMP

Where it's running

• CCU Transltional Immunolgy, University Hospital Tübingen
  Tübingen, Baden-Wurttemberg, Germany Recruiting
• NCT Studienzentrale; Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg
  Heidelberg, Baden-Wurttemberg, Germany Not yet recruiting
• Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin - Studienzentrale Onkologie
  Berlin, Beriln, Germany Not yet recruiting
• Universitätsklinikum Essen, Abteilung Urologie
  Essen, North Rhine-Westphalia, Germany Not yet recruiting

Study contacts

• Study coordinator: Susanne Jung, Dr. med.
• Email: kketi@med.uni-tuebingen.de
• Phone: +49 (0)7071-29 83275

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.