Dendritic cells vaccination after allogeneic stem cell transplantation

Vaccination with minor histocompatibility antigen-loaded donor DC vaccines to boost graft-versus-tumor immunity after allogeneic stem cell transplantation - MiHA-loaded DC vaccination after allogeneic SCT

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-002879-34-NL

Enrollment

Unknown

Registered

2012-08-24

Start date

2013-03-05

Completion date

Unknown

Last updated

2016-08-08

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

Conditions

Patients with aggressive hematological malignancies treated with allogeneic stem cell transplantation

Interventions

Product Name: MiHA-TC-DC product Product Code: MiHA-TC-DC product Pharmaceutical Form: Infusion Other descriptive name: MiHA mRNA transfected Dendritic Cell product Concentration unit: Other Concent

Eligibility

Sex/Gender

All

Inclusion criteria

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, HLA-A24, HLA-B7 and/or HLA-B44 • Patients positive for HA-1, LRH-1 and/or ARHGDIB transplanted with corresponding MiHA-negative donor • Patients >18 and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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
Timepoint(s) of evaluation of this end point: Participating patients will visit the outpatient clinic weekly or two-weekly for standard physical examination and blood sampling from the first DC vaccination until 4 and 12 weeks after vaccination, respectively. For follow-up, peripheral blood will be collected from patients pre-study, at day 0, 7, 14, 21, 28, 42, 63 and 84 during and after DC vaccinations. The total amount of blood that will be taken for study purposes will be maximally 282 ml in a three month period. Two extra bone marrow aspirations will be performed (day 42 and 84 after first DC vaccination). ;Primary end point(s): 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 electroporated with mRNA encoding hematopoietic-restricted MiHA in patients who had undergone allo-SCT with stem cells from HLA-matched, MiHA-mismatched donor. ;Main Objective: The primary objectives of our study are to evaluate safety, toxicity and capability of inducing T cell responses of vaccination with monocyte-derived donor DC electroporated with mRNA encoding hematopoietic-restricted MiHA in patients who had undergone allo-SCT with stem cells from HLA-matched, MiHA-mismatched donor. ;Secondary Objective: The secondary objective is to evaluate the clinical effect of vaccination in case of detectable minimal residual disease and mixed chimerism.	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: Participating patients will visit the outpatient clinic weekly or two-weekly for standard physical examination and blood sampling from the first DC vaccination until 4 and 12 weeks after vaccination, respectively. For follow-up, peripheral blood will be collected from patients pre-study, at day 0, 7, 14, 21, 28, 42, 63 and 84 during and after DC vaccinations. The total amount of blood that will be taken for study purposes will be maximally 282 ml in a three month period. Two extra bone marrow aspirations will be performed (day 42 and 84 after first DC vaccination). ;Primary end point(s): 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 electroporated with mRNA encoding hematopoietic-restricted MiHA in patients who had undergone allo-SCT with stem cells from HLA-matched, MiHA-mismatched donor. ;Main Objective: The primary objectives of our study are to evaluate safety, toxicity and capability of inducing T cell responses of vaccination with monocyte-derived donor DC electroporated with mRNA encoding hematopoietic-restricted MiHA in patients who had undergone allo-SCT with stem cells from HLA-matched, MiHA-mismatched donor. ;Secondary Objective: The secondary objective is to evaluate the clinical effect of vaccination in case of detectable minimal residual disease and mixed chimerism.

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Secondary

Measure	Time frame
Secondary end point(s): The secondary study parameters are to evaluate the clinical effect of MiHA-DC vaccination in case of detectable minimal residual disease and mixed chimerism.;Timepoint(s) of evaluation of this end point: Participating patients will visit the outpatient clinic weekly or two-weekly for standard physical examination and blood sampling from the first DC vaccination until 4 and 12 weeks after vaccination, respectively. For follow-up, peripheral blood will be collected from patients pre-study, at day 0, 7, 14, 21, 28, 42, 63 and 84 during and after DC vaccinations. The total amount of blood that will be taken for study purposes will be maximally 282 ml in a three month period. Two extra bone marrow aspirations will be performed (day 42 and 84 after first DC vaccination).	—

Measure

Time frame

Secondary end point(s): The secondary study parameters are to evaluate the clinical effect of MiHA-DC vaccination in case of detectable minimal residual disease and mixed chimerism.;Timepoint(s) of evaluation of this end point: Participating patients will visit the outpatient clinic weekly or two-weekly for standard physical examination and blood sampling from the first DC vaccination until 4 and 12 weeks after vaccination, respectively. For follow-up, peripheral blood will be collected from patients pre-study, at day 0, 7, 14, 21, 28, 42, 63 and 84 during and after DC vaccinations. The total amount of blood that will be taken for study purposes will be maximally 282 ml in a three month period. Two extra bone marrow aspirations will be performed (day 42 and 84 after first DC vaccination).

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Countries

Netherlands

Contacts

Public ContactTrial Data Center

Radboud University Nijmegen Medical Centre

Datacentrum@HEMAT.umcn.nl31243614794

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026