Tumor Antigen loaded Dendritic Cell Vaccination for hematological malignancies after allogeneic transplantatio

Phase 1

• Conditions: MedDRA version: 18.1Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864; Multiple Myeloma (MM), Chronic Lymphocytic Leukemia (CLL), non Hodgkin lymphoma (nHL)(any grade), Hodgkin’s lymphoma (HL).; MedDRA version: 18.1Level: LLTClassification code 10020309Term: Hodgkin's disease, unspecified typeSystem Organ Class: 100000004864; MedDRA version: 18.1Level: LLTClassification code 10066703Term: Non-Hodgkin's lymphoma progressionSystem Organ Class: 100000004864; MedDRA version: 18.1Level: LLTClassification code 10068919Term: B-cell chronic lymphocytic leukemiaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-003554-41-NL
• Lead Sponsor: VU University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-19
• Last Update Posted: 26 March 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1. Patients with Multiple Myeloma (MM), Chronic Lymphocytic Leukemia (CLL), non hodgkin lymphoma (any grade), Hodgkin’s lymphoma (HL),
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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 8
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: -To evaluate the efficacy of a DLI-combined minor H ag UTA2-1 peptide-loaded, PD-L silenced donor DC vaccination and DLI to induce a GvT for B cell hematological malignancies. <br>- To evaluate the toxicity and feasibility of a DLI-combined minor H ag UTA2-1 peptide-loaded, PD-L silenced donor DC in B cell hematological malignancies<br><br>;Secondary Objective: - To evaluate the effect of a combined minor H ag UTA2-1 peptide-loaded, PD-L silenced donor DC vaccination and DLI on the immune status of the recipient in correlation with toxicity and response ;Primary end point(s): - CTC toxicity grade 4 and death directly related to the DC infusions<br><br>- Acute GvHD grade 3 and 4 <br><br><br>;Timepoint(s) of evaluation of this end point: time points are during the infusion period every two weeks. Hereafter every 4 weeks until progression or reaching the stopping rules

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Clinical response and duration of response <br>- Immune effects including minor Hag UTA2-1-specific CD8+ T cell responses<br>;Timepoint(s) of evaluation of this end point: time points are during the infusion period every two weeks. Hereafter every 4 weeks until progression or reaching the stopping rules