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A phase I/II trial to boost the graft-versus-tumor effect of Allogeneic Stem Cell Transplantation by vaccination with PD-L silenced, minor histocompatibility antigen UTA2-1 peptide-loaded Dendritic Cells

A phase I/II trial to boost the graft-versus-tumor effect of Allogeneic Stem Cell Transplantation by vaccination with PD-L silenced, minor histocompatibility antigen UTA2-1 peptide-loaded Dendritic Cells - mHag UTA2-1-loaded PD-L silenced DC vaccination after allo SCT

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON44197
Enrollment
12
Registered
2018-01-22
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

bloed cell cancer hematological lymphoid and myeloid malignancies

Interventions

Suitable patients will be vaccinated with ex vivo cultured donor DCs that are a) silenced for PD-L molecules by means of a siRNA transfection methodology and b) loaded with peptides of the UTA2-1 an

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

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 mHag positive, donor mHag negative). 4. Recipient and donor are positive for HLA-A*0201 5. Age 18-75 years 6. Absence of acute GvHD > grade 1 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

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-L silenced donor DC vaccination on the immune status of the recipient in correlation with toxicity and response, including the investigation of 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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)