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 (B-cell therapy)

University of Erlangen-Nürnberg Medical School

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Multiple Myeloma; Hodgkin's Disease; Chronic Myeloid Leukemia; Acute Lymphoblastic Leukemia; Aplastic Anemia; Myelodysplastic Syndrome; Acute Myeloid Leukemia; Non Hodgkin's Lymphoma

Treatments: Biological: allogeneic donor derived B-lymphocytes

Study type: Interventional

Funder types: Other

Identifiers

NCT02007811

UKER-BLZ-PH1

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

allogeneic donor derived B-lymphocytes

Experimental group

Treatment:

Biological: allogeneic donor derived B-lymphocytes