MiHA-loaded PD-L-silenced DC Vaccination After Allogeneic SCT

• Register: ClinicalTrials.gov
• Last refreshed on: 12 April 2021
• Main ID: NCT02528682
• Date of registration: 18/08/2015
• Prospective Registration: Yes
• Primary sponsor: Radboud University
• Public title: MiHA-loaded PD-L-silenced DC Vaccination After Allogeneic SCT PSCT19
• Scientific title: Vaccination With PD-L1/L2-silenced Minor Histocompatibility Antigen-loaded Donor DC Vaccines to Boost Graft-versus-tumor Immunity After Allogeneic Stem Cell Transplantation (a Phase I/II Study)
• Date of first enrolment: January 2016
• Target sample size: 10
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02528682
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

Netherlands

Contacts

• Name: Nicolaas Schaap, MD/PhD
• Affiliation: Radboud University

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with AML, myelodysplasia (MDS), ALL, CML (accelerated or blast phase), CLL,
MM, malignant NHL or HL, who underwent HLA-matched allo-SCT

- Patients positive for HLA-A2 and/or HLA-B7

- Patients positive for HA-1, LRH-1 and/or ARHGDIB transplanted with corresponding
MiHA-negative donor

- Patients =18 years of age

- WHO performance 0-2

- Witnessed written informed consent

Exclusion Criteria:

- Life expectancy < 3 months

- Severe neurological or psychiatric disease

- Progressive disease needing cytoreductive therapy

- HIV positivity

- Patients with acute GVHD grade 3 or 4

- Patients with severe chronic GVHD

- Patients with active infections (viral, bacterial or fungal) that require specific
therapy. Acute anti-infectious therapy must have been completed within 14 days prior
to study treatment

- Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive
heart failure or symptomatic ischemic heart disease)

- Severe pulmonary dysfunction

- Severe renal dysfunction (serum creatinine > 3 times normal level)

- Severe hepatic dysfunction (serum bilirubin or transaminases > 3 times normal level)

- Patients with known allergy to shell fish



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hematological Malignancies

Intervention(s)

Biological: MiHA-loaded PD-L-silenced DC Vaccination

Primary Outcome(s)

Development of GVHD [Time Frame: From day 0 until day 84]

The generation and magnitude of an immunological response [Time Frame: From day 0 until day 84]

Evaluation of toxicity [Time Frame: From day 0 until day 84]

Secondary Outcome(s)

Disappearance of residual disease [Time Frame: day 0, day 14, day 28, day 64, day 84]

Changes in chimerism [Time Frame: day 0, day 14, day 28, day 64, day 84]

Secondary ID(s)

PSCT19

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Dutch Cancer Society

ZonMw: The Netherlands Organisation for Health Research and Development