PSCT19 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)

PSCT19 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) - MiHA-loaded PD-L-silenced DC vaccination after allogeneic SCT, PSCT19

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41198

Enrollment

Registered

2014-11-21

Start date

2016-04-08

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

blood cell cancer hematological malignancies

Interventions

Eligible patients will receive one cycle of donor DC vaccination consisting of maximal 3 immunizations, given at 2 week intervals. PD-L1/L2-silenced MiHA mRNA-electroporated donor DC will be infused

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patient inclusion criteria * Patients with AML, myelodysplasia (MDS), ALL, CML (accelerated or blast phase), CLL, MM or malignant NHL, 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

Exclusion criteria

Exclusion criteria: Patient exclusion criteria * Life expectancy 3 times normal level) * Severe hepatic dysfunction (serum bilirubin or transaminases > 3 times normal level) * Patients with known allergy to shell fish

Design outcomes

Primary

Measure	Time frame
The primary study parameters are to evaluate the safety, toxicity, development of GVHD and the immunological response by appearance of MiHA-specific CD8+ T cells following vaccination with monocyte-derived donor DC transfected with PD-L1/L2 siRNA and electroporated with mRNA encoding hematopoietic-restricted MiHA in patients who had undergone allo-SCT with stem cells from HLA-matched, MiHA-mismatched donor.	—

Measure

Time frame

The primary study parameters are to evaluate the safety, toxicity, development of GVHD and the immunological response by appearance of MiHA-specific CD8+ T cells following vaccination with monocyte-derived donor DC transfected with PD-L1/L2 siRNA and electroporated with mRNA encoding hematopoietic-restricted MiHA in patients who had undergone allo-SCT with stem cells from HLA-matched, MiHA-mismatched donor.

—

Secondary

Measure	Time frame
The secondary study parameters are to evaluate the clinical effect of MiHA-DC vaccination in case of detectable minimal residual disease and mixed chimerism.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)