Cytomegalovirus - Immunoprophylactic Adoptive Cellular Therapy Study

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the potential clinical benefit of prophylactic cytomegalovirus (CMV)-specific adoptive cellular therapy following T cell depleted allogeneic hematopoietic stem cell transplantation (HSCT) for reducing recurrent CMV reactivation.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cell Medica Ltd
• Collaborators: BioAnaLab; Commitum AB; EMAS Pharma; Wellcome Trust
• Treatments: Antiviral Agents

Criteria

Inclusion Criteria:

• Suitable participants will be selected from patients already scheduled to undergo a T cell depleted sibling donor HSCT. The criteria will include:

• Age 18 years or older

• Negative markers of Infectious Disease screen

• Recipient of allogeneic HSCT (that incorporates T cell depletion with alemtuzumab) who is CMV seropositive with a CMV seropositive sibling donor

• Informed consent from both donor and patient and to be assessed prior to CMV-specific T cell infusion (confirmed prior to product release):

• Donor engraftment (neutrophils > 0.5x109/l)

Exclusion Criteria:

• Pregnant or lactating women

• Co-existing medical problems that would place the patient at significant risk of death due to GVHD or its sequelae

• HIV infection and to be assessed prior to CMV-specific T cell infusion (confirmed prior to product release):

• Active acute GVHD > Grade I

• Concurrent use of systemic corticosteroids

• Organ dysfunction as measured by

1. creatinine > 200 uM/l

2. bilirubin > 50 uM/l

3. ALT > 3x upper limit of normal