A phase I/II *minor histocompatibility antigen UTA2-1 loaded, PD-L silenced Dendritic cell vaccination trial after allogeneic Stem Cell Transplantation to improve the safety and efficacy of Donor Lymphocyte Infusions.

Phase 2

Withdrawn

Conditions: hematological B cell malignancies blood cell cancer
10027656

Registration Number: NL-OMON43853

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 12

Inclusion Criteria

1. Patients with Multiple Myeloma (MM), Chronic Lymphocytic Leukemia (CLL), non hodgkin lymphoma (any grade),
2. Proven residual disease (including as determined by disease-specific or patient-specific PCR) minimally 6 months after allogeneic Stem Cell Transplantation (allo-SCT) and subsequent persistent or relapsed disease after a first therapeutic DLI
3. 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 1 or extensive chronic GvHD
7. No treatment with immunosuppressive drugs such as prednisone, cyclosporine A and MMF at least 8 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

1. WHO performance 3-4
2. Presence of severe cardiac hepatic, renal, metabolic disease
3. Rapidly progressive disease, despite reinduction therapy
4. Life expectancy < 3 months

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study parameters are<br /><br>-To evaluate the toxicity and feasibility of a DLI-combined minor H ag UTA2-1<br /><br>peptide-loaded, PD-L silenced donor DC vaccination in B cell hematological<br /><br>malignancies<br /><br>- To evaluate the effect of a DLI-combined minor H ag UTA2-1 peptide-loaded,<br /><br>PD-L silenced donor DC vaccination on the immune status of the recipient in<br /><br>correlation with toxicity and response, including the investigation of the<br /><br>induction of UTA2-1 specific T cell responses after vaccination.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Te secundary study parameter is to evaluate the efficacy of the DLI-combined<br /><br>minor H ag UTA2-1 peptide-loaded, PD-L silenced donor DC vaccination to induce<br /><br>a GvT for B cell hematological malignancies. </p><br>