E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Multiple Myeloma (MM), Chronic Lymphocytic Leukemia (CLL), non Hodgkin lymphoma (nHL)(any grade), Hodgkin’s lymphoma (HL). |
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E.1.1.1 | Medical condition in easily understood language |
Blood cell (B and plasma cell) cancers. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020309 |
E.1.2 | Term | Hodgkin's disease, unspecified type |
E.1.2 | System Organ Class | 100000004864 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10066703 |
E.1.2 | Term | Non-Hodgkin's lymphoma progression |
E.1.2 | System Organ Class | 100000004864 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10028228 |
E.1.2 | Term | Multiple myeloma |
E.1.2 | System Organ Class | 100000004864 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10068919 |
E.1.2 | Term | B-cell chronic lymphocytic leukemia |
E.1.2 | System Organ Class | 100000004864 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
-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. - 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
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E.2.2 | Secondary objectives of the trial |
- 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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
- CTC toxicity grade 4 and death directly related to the DC infusions
- Acute GvHD grade 3 and 4
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E.5.1.1 | 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 |
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E.5.2 | Secondary end point(s) |
- Clinical response and duration of response - Immune effects including minor Hag UTA2-1-specific CD8+ T cell responses
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E.5.2.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | Yes |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the study is defined as the last patient’s last visit. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |