This study is assessing the feasibility of generating expanded T cells for the treatment of cytomegalovirus (CMV) reactivation and disease, and the subsequent evaluation of safety.

Phase 1

Completed

• Conditions: Cytomegalovirus; Infection - Other infectious diseases

• Registration Number: ACTRN12613000981729
• Lead Sponsor: QIMR Berghofer Medical Research Institute.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-03
• Last Update Posted: 20 March 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Outcome 1: To determine the feasibility of generating ex-vivo expanded polyclonal CMV-specific T cells from SOT (solid organ transplant) recipients.<br>Assessed by: Medical History, physical examination, vital signs, blood tests. <br>[Screening ];Primary Outcome 2: To determine the safety of adoptive transfer of up to six doses of CMV-specific T cells into SOT recipients with CMV reactivation or disease.<br>Assessed by: Reporting of adverse events such as fatigue, fever, high blood pressure, or pain, clinical history, physical examination, vital observations, and laboratory blood studies[Weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 18, 22, 26, 30, 34, 38, and 42]

Secondary Outcome Measures

Name	Time	Method
nil[not applicable]