B-cell therapy: 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

Sponsor

University of Erlangen-Nürnberg Medical School (Other)

Overall Status

Unknown status

CT.gov ID

NCT02007811

Collaborator

University Hospital Regensburg (Other), Wuerzburg University Hospital (Other), University Hospital, Essen (Other), German Research Foundation (Other)

Enrollment

Location

Arm

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Chronic Myeloid Leukemia Non Hodgkin's Lymphoma Hodgkin's Disease Myelodysplastic Syndrome Multiple Myeloma Aplastic Anemia	Biological: allogeneic donor derived B-lymphocytes	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2015

Anticipated Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: allogeneic donor derived B-lymphocytes	Biological: allogeneic donor derived B-lymphocytes CD3+-depleted, CD19+-enriched, cryopreserved (single administration after day 120 following allogeneic stem cell transplantation, donor-identical) in 4 groups with escalating doses

Arm

Intervention/Treatment

Experimental: allogeneic donor derived B-lymphocytes

Biological: allogeneic donor derived B-lymphocytes

CD3+-depleted, CD19+-enriched, cryopreserved (single administration after day 120 following allogeneic stem cell transplantation, donor-identical) in 4 groups with escalating doses

Outcome Measures

Primary Outcome Measures

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]

Secondary Outcome Measures

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]
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]