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Vaccination with minor histocompatibility antigen-loaded donor DC vaccines to boost graft-versus-tumor immunity after allogeneic stem cell transplantation (a phase I study)

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON40014
Enrollment
10
Registered
2012-08-23
Start date
2014-01-20
Completion date
Unknown
Last updated
2025-03-24

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. MiHA mRNA-electroporated donor DC will be infused intravenously (2.

Sponsors

Universitair Medisch Centrum Sint Radboud
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

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 and/or HLA-B7 * Patients positive for HA-1, LRH-1 and/or ARHGDIB transplanted with corresponding MiHA-negative donor * Patients >18 and

Exclusion criteria

Exclusion criteria: * Life expectancy

Design outcomes

Primary

MeasureTime 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 electroporated with mRNA encoding hematopoietic-restricted MiHA in patients who had undergone allo-SCT with stem cells from HLA-matched, MiHA-mismatched donor.

Secondary

MeasureTime 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)