Phase I open label clinical trial of autologous T cell therapy for the treatment of cytomegalovirus (CMV) reactivation and disease after transplantation

QIMR Berghofer Medical Research Institute.0 sites30 target enrollmentSeptember 3, 2013

Overview

No summary available.

Registry

who.int

Start Date

September 3, 2013

End Date

TBD

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\) Transplant recipients who were transplanted by, and/or are currently under the care of, a physician at the appropriate clinical facility.
•2\). CMV infection that falls into one of the following categories:
•(2a) CMV reactivation (as defined by PCR) or disease (as defined by histology) following successful initial therapy, or
•(2b) Persistent CMV disease (no response to 2 weeks of salvage foscarnet or other second line antiviral agent), or
•(2c) Persistent CMV replication (more than 6 weeks by PCR) despite appropriate antiviral therapy, or
•(2d) Any CMV reactivation or disease where anti\-viral therapy is contraindicated on the basis of intolerance or end organ limitation (e.g. renal impairment, marrow dysfunction).
•3\) Absence of uncontrolled intercurrent infection
•4\) Patient able to provide informed consent
•5\) Aged 18 to 75

•1\) Uncontrolled intercurrent infection
•2\) ECOG status greater than 3 (Karnofsky performance score less than 30 : disabled, no self\-care. Totally bedridden, or confined to chair)
•3\) Markers of active HBV, HCV, HIV, HTLV I and II and syphilis infection (presence of HbsAg, HepC antibody, HIV antibody, antibodies to HTLV I and II and positive serological test for syphilis, or positive nucleic acid test (NAT) for HIV, HBV or HCV)
•4\) Uncontrolled graft rejection.
•5\) Steroid doses greater than 1mg/kg/day of prednisone, or equivalent
•6\) Insufficient T cells for in vitro expansion
•7\) Women who are lactating, pregnant, or unwilling to use adequate contraception