Skip to content

mHag UTA2-1 loaded PD-L silenced DC vaccination after allo SCT

A phase I/II trial towards the safety and efficacy of preemptive vaccination with PD-L silenced, minor histocompatibility antigen UTA2-1 peptide-loaded Dendritic Cells after Allogeneic Stem Cell Transplantation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22602
Enrollment
17
Registered
2019-07-01
Start date
2019-08-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multipel Myeloma (MM), Chronic Lymphocytic Leukemia (CLL), Non Hodgkin Lymphoma (NHL)

Interventions

Patients will be vaccinated with ex vivo cultured, UTA2-1 peptide loaded donor DCs that are furthermore silenced for PD-L1/L2 molecules via siRNA transfection DCs will be administered at a total dose

Sponsors

VU University Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with Multiple Myeloma (MM) or Chronic Lymphocytic Leukemia (CLL) or non hodgkin lymphoma (any grade) or acute myeloid leukemia (AML) 2. Recipient and donor have a mismatch in UTA2-1 mHag in the Graft versus Tumor (GvT) direction (recipient UTA2-1 positive, donor UTA2-1 negative). 4. Recipient and donor are positive for HLA-A*0201 5. Age 18-75 years 6. Absence of acute GvHD > grade 2 or extensive chronic GvHD 7. No treatment with immunosuppressive drugs such as prednisone, cyclosporine A and MMF at least 4 weeks prior to planned vaccination date. 8. WHO performance 0-2 9. Absence of severe cardiac hepatic, renal, or metabolic disease 10. Written informed consent

Exclusion criteria

Exclusion criteria: 1. WHO performance 3-4 2. Presence of severe cardiac hepatic, renal, metabolic disease 3. Rapidly progressive disease, 4. Life expectancy < 3 months

Design outcomes

Primary

MeasureTime frame
-To evaluate the toxicity and feasibility of a preemptive minor H ag UTA2-1 peptide-loaded, PD-L silenced donor DC vaccination - To evaluate the effect of minor H ag UTA2-1 peptide-loaded, PD-L1/2 silenced donor DC vaccination on the immune status of the recipient in correlation with the induction of UTA2-1 specific T cell responses after vaccination.

Secondary

MeasureTime frame
-to evaluate the efficacy of the minor H ag UTA2-1 peptide-loaded, PD-L silenced donor DC vaccination to induce a GvT effect.

Contacts

Public ContactTuna Mutis

Amsterdam UMC, locatie VUmc

t.mutis@amsterdamumc.nl00 31 20 4442604

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)