Clinical trial · Interventional
Open-label Clinical Trial to Investigate the Safety and Tolerability of Allogeneic B-cell Concentrates for Immune Reconstitution After Allogeneic Stem Cell Transplantation Measured as Response to a Antedated Single Vaccination
Prospective, Open-label, Multicentre Clinical Trial, Phase I/IIa, to Investigate the Safety and Tolerability of Allogeneic B-cell Concentrates CD3+-Depleted, CD19+-Enriched, Cryopreserved (Single Administration After Day 120 Following Allogeneic Stem Cell Transplantation (SCT), Donor-identical) in 4 Groups With Escalating Doses for Immune Response Enhancement, Measured as Response to a Antedated Single Vaccination
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Aplastic Anemia | — | UNRESOLVED | — |
| Chronic Myeloid Leukemia | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Hodgkin's Disease | Hodgkin Lymphoma | ALIAS | 0.90 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
| Non Hodgkin's Lymphoma | Non-Hodgkin Lymphoma |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allogeneic donor derived B-lymphocytes | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- allogeneic donor derived B-lymphocytes
- interventionNames
- Biological: allogeneic donor derived B-lymphocytes
Primary outcomes (3)
- measure
- Number of participants with EBV DNA copies/ml plasma higher than 50,000
- timeFrame
- for 120 days after administration of study medication
- measure
- Number of participants with signs of a post-transplant lymphoproliferative disorder (PTLD)
- timeFrame
- for 120 days after administration of study medication
- measure
- 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)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. patients after allogeneic stem cell transplantation 2. Serostatus for EBV: R-/D- oder R+/D- oder R+/D+ Exclusion Criteria: 1. Serostatus for EBV: R-/D+ 2. Severe acute Graft versus Host Disease (GvHD) (Glucksberg grade III und IV) 3. Chronic GvHD in middle- or high-risk group according to NIH staging 4. Rituximab administration after SCT 5. \>10.000 EBV DNA copies/ml plasma 6. Recurrence of the haematological disorder needing therapeutic intervention 7. Secondary transplantation 8. SCT with transplant from a haploidentical donor 9. SCT with transplant from umbilical cord blood 10. CD34+-enriched transplant 11. in vitro T-cell depleted transplant 12. Pregnant or breast-feeding female
References
Publications (1)
- DERIVEDWinkler 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. PMID 38467031