Preventative/Preemptive Adoptive Transfer of Peptide Stimulated CMV/EBV Specific T-cells in Patients After Allogeneic Stem Cell Transplantation

University of Erlangen-Nürnberg Medical School

Status and phase: Completed; Phase 2; Phase 1

Conditions: Patients Undergoing Allogeneic Stem Cell Transplantation

Treatments: Biological: CMV/EBV specific T-cell

Study type: Interventional

Funder types: Other

Identifiers

NCT02227641

2012-004240-30 (EudraCT Number)

AIT-MULTIVIR-01

Details and patient eligibility

About

In patients after allogeneic stem cell transplantation reactivation of latent herpesviruses such as Cytomegalovirus (CMV) and Epstein Barr Virus (EBV) is a frequent and life threatening complication requiring antiviral treatment. The underlying problem is a severe suppression of the donors immune system after transplantation into the patient. Herpesviruses such as CMV and EBV persist after primary infection life long in the host and therefore require constant immunological control. This control is largely provided by the T-cell compartment of the immune system. After allogeneic stem cell transplantation the T-cell compartment requires a long time for its reconstitution since only a small fraction of the donor T-cells are transplanted. During this time Herpesviruses can reoccur due to the lack of effective T-cell control.

This study therefore aims at reconstituting the T-cell compartment with CMV and EBV specific T-cells at an early time point after allogeneic stem cell transplantation. It is mainly a phase I study to demonstrate that these in vitro generated T-cells can be applied safely in this patient population. The study also aims at demonstrating the efficacy of CMV/EBV specific T-cells by monitoring viral reactivation and use of antiviral drugs. The hypothesis is, that CMV/EBV specific T-cell can be applied safely and do not result in graft versus host disease and that they successfully prevent reactivation of CMV and EBV after adoptive transfer in patients after allogeneic stem cell transplantation.

Enrollment: 50 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Indication for allogeneic stem cell transplantation
• HLA identical donor, related or unrelated, 10/10 match
• Stem cell source: G-SCF mobilized peripheral blood stem cells
• Presence of at least one HLA allele: A0101, A0201, B0702, B0801, B3501, C0702
• Positive EBV serology of the donor
• Positive CMV serology of the donor
• Adequate contraception

Exclusion criteria

• Donor CMV seronegative
• Donor EBV seronegative
• Stem cell source: bone marrow or cord blood
• Alemtuzumab for conditioning
• Sorror Score >3
• Pregnancy

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Adoptive transfer of CMV/EBV specific T-cells

Experimental group

Description:

Repetitive adoptive T-cell transfer starting at day 30 after allogeneic stem cell transplantation.

Treatment:

Biological: CMV/EBV specific T-cell

Control

No Intervention group

Description:

Observation only.