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| Name | Class |
|---|---|
| University Hospital Regensburg | OTHER |
| Wuerzburg University Hospital | OTHER |
| University Hospital, Essen | OTHER |
| German Research Foundation |
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The reconstitution of a functioning immune system after allogeneic stem cell transplantation takes months to years. Particularly memory B-lymphocytes reconstitute poorly with the current conditioning regimes. During the period of intense immune suppression the patients are extremely susceptible to bacterial, fungal and, most importantly, viral infections.The adoptive transfer of B-lymphocytes from the stem-cell donor might significantly enhance humoral immunity for the patient. Aim of the study is to evaluate a new cellular therapy with B-lymphocytes regarding safety. A booster vaccination after B-lymphocyte transfer will evaluate the functionality of the transferred B-lymphocytes in the patient.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| allogeneic donor derived B-lymphocytes | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| allogeneic donor derived B-lymphocytes | Biological | CD3+-depleted, CD19+-enriched, cryopreserved (single administration after day 120 following allogeneic stem cell transplantation, donor-identical) in 4 groups with escalating doses |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with EBV DNA copies/ml plasma higher than 50,000 | for 120 days after administration of study medication | |
| Number of participants with signs of a post-transplant lymphoproliferative disorder (PTLD) | for 120 days after administration of study medication | |
| Number of participants with adverse events (AEs), adverse reactions (ARs), serious adverse events (SAEs), serious adverse reactions (SARs) and suspected unexpected serious adverse reaction (SUSARs) | for 120 days after administration of study medication |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the frequency of antibody-producing cells between dose groups | before and 7 days after preponed single vaccination | |
| Change of mean absolute number of B-lymphocytes, naïve B-lymphocytes and memory B-lymphocytes between dose groups. | 1 day before and up to 120 days after administration of study medication |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julia Winkler, MD | Contact | +49 9131 85 43112 | julia.winkler@uk-erlangen.de | |
| Wolf Rösler, MD | Contact | +49 9131 85 43115 | wolf.roesler@uk-erlangen.de |
| Name | Affiliation | Role |
|---|---|---|
| Julia Winkler, MD | University Hospital Erlangen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Department 5, University Hospital Erlangen | Recruiting | Erlangen | 91054 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38467031 | Derived | Winkler J, Tittlbach H, Schneider A, Vasova I, Strobel J, Herold S, Maas S, Spriewald BM, Repp R, Kordelas L, Mach M, Wolff D, Edinger M, Mackensen A, Winkler TH. Adoptive transfer of donor B lymphocytes: a phase 1/2a study for patients after allogeneic stem cell transplantation. Blood Adv. 2024 May 28;8(10):2373-2383. doi: 10.1182/bloodadvances.2023012305. |
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| OTHER |
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| Change of antigen-specific antibody concentration in serum/plasma between dose groups | 1 day before and up to 120 days after administration of study medication |
| Change of Cytomegalovirus (CMV) DNA copies/ml plasma between dose groups | 1 day before and up to 120 days after administration of study medication |
| Number of patients with >5,000 CMV DNA copies/ml plasma or with signs of organ infestation by CMV between dose groups. | up to 120 days after administration of study medication |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D008228 | Lymphoma, Non-Hodgkin |
| D006689 | Hodgkin Disease |
| D009190 | Myelodysplastic Syndromes |
| D009101 | Multiple Myeloma |
| D000741 | Anemia, Aplastic |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008223 | Lymphoma |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D000740 | Anemia |
| D000080983 | Bone Marrow Failure Disorders |
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