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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
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.
Scientific title
Phase I open label clinical trial of autologous T cell therapy for the treatment of cytomegalovirus (CMV) reactivation and disease after transplantation
Secondary ID [1] 283111 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cytomegalovirus 289958 0
Condition category
Condition code
Infection 290329 290329 0 0
Other infectious diseases

Study type
Description of intervention(s) / exposure
There will be a single treatment arm. Patients will donate 250 - 300mL of blood, from which T cells will be isolated and expanded. A minimum of 2 and a maximum of 6 intravenous infusions of 1-2 x10e7 /m2 autologous ex vivo expanded, polyclonal, bulk, CMV-specific T cells will be given at weeks 0,2,4,6,10 and 14. The number of infusions may be limited by the number of cells generated.
Intervention code [1] 287830 0
Treatment: Other
Comparator / control treatment
Control group

Primary outcome [1] 290361 0
Primary Outcome 1: To determine the feasibility of generating ex-vivo expanded polyclonal CMV-specific T cells from SOT (solid organ transplant) recipients.
Assessed by: Medical History, physical examination, vital signs, blood tests.
Timepoint [1] 290361 0
Primary outcome [2] 290362 0
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.
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
Timepoint [2] 290362 0
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 [1] 313367 0
Timepoint [1] 313367 0
not applicable

Key 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
Minimum age
18 Years
Maximum age
75 Years
Both males and females
Can healthy volunteers participate?
Key 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
Purpose of the study
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Single group
Other design features
Phase 1
Type of endpoint(s)
Statistical methods / analysis
Safety: The primary measure of safety of CTL adoptive transfer is via adverse events reporting. These will be represented and assessed as follows. 1. Line listings of individuals with clinical and laboratory adverse reactions. 2. Summaries of adverse clinical events including graft versus host disease by severity and relation to adoptive transfer of CMV-CTL 3. Shift tables for laboratory parameters. 4. Graphical representation of selected laboratory values over time. Sample Size: Given 30 participants with 6 exposures per participant the study has a 0.999 probability of observing at least one participant experiencing an adverse event if the probability of that event occurring is assumed to be 0.2 and every exposure produces the AE in those people who are susceptible. Equivalent probabilities for observing AEs which affect 1 in 10 people and 1 in 15 people are 0.958 and 0.874 respectively. Alternatively, using exact (binomial) confidence intervals, if 0 of the 30 participants experienced a particular AE, we would be 95% confident that the population rate for this AE lies somewhere in the range 0% to 11.6%. If 1 of the 30 participants experienced a particular AE, the corresponding 95% confidence interval is 0.08% to 17.2% and for 2 of 30 the 95% confidence interval is 0.08% to 22.1%.

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 1461 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 1462 0
The Prince Charles Hospital - Chermside
Recruitment hospital [3] 3535 0
The Royal Adelaide Hospital - Adelaide

Funding & Sponsors
Funding source category [1] 287866 0
Name [1] 287866 0
QIMR Berghofer Flagship Program on Immunotherapy
Address [1] 287866 0
QIMR Berghofer Medical Research Institute
300 Herston Rd, Herston, QLD 4006
Country [1] 287866 0
Primary sponsor type
QIMR Berghofer Medical Research Institute.
300 Herston Rd, Herston, QLD 4006
Secondary sponsor category [1] 286595 0
Name [1] 286595 0
Address [1] 286595 0
Country [1] 286595 0
Other collaborator category [1] 277595 0
Name [1] 277595 0
A/Prof. Daniel Chambers
Address [1] 277595 0
The Prince Charles Hospital
Rode Road
Chermside Qld 4032
Country [1] 277595 0
Other collaborator category [2] 278378 0
Name [2] 278378 0
Associate Professor Scott Campbell
Address [2] 278378 0
Princess Alexandra Hospital
Ipswich Rd, Woolloongabba, Qld 4103
Country [2] 278378 0
Other collaborator category [3] 278379 0
Name [3] 278379 0
Dr Chien-Li Holmes-Liew
Address [3] 278379 0
Royal Adelaide Hospital, North Terrace, Adelaide SA 5000
Country [3] 278379 0

Ethics approval
Ethics application status
Ethics committee name [1] 289810 0
Queensland Institute of Medical Research Human Research Ethics Committee
Ethics committee address [1] 289810 0
QIMR Berghofer Medical Research Institute.
300 Herston Rd
Herston QLD 4006
Ethics committee country [1] 289810 0
Date submitted for ethics approval [1] 289810 0
Approval date [1] 289810 0
Ethics approval number [1] 289810 0
Ethics committee name [2] 292475 0
Metro North Hospital and Health Service Human Research Ethics Committee
Ethics committee address [2] 292475 0
The Prince Charles Hospital, Rode Rd, Chermside Qld 4032
Ethics committee country [2] 292475 0
Date submitted for ethics approval [2] 292475 0
Approval date [2] 292475 0
Ethics approval number [2] 292475 0

Brief summary
This study involves participants who have undergone solid organ transplantation and are either experiencing human cytomegalovirus (CMV) disease or are at risk of developing it. The study is assessing the feasibility of generating T cells (a type of white blood cell) that target CMV, and the effect of these cells when infused into participants. Eligible participants will donate 250-300mL of blood to expand CMV-specific T cells which will form their treatment. Participants will receive 2-6 intravenous infusions of T cells. The effects of the treatment will be studied by monitoring signs and symptoms and by blood tests. Total length of involvement in the study will be no longer than 10 months.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 42542 0
Prof Rajiv Khanna
Address 42542 0
QIMR Berghofer Medical Research Institute.
300 Herston Rd, Herston QLD 4006
Country 42542 0
Phone 42542 0
+61 7 3362 0385
Fax 42542 0
+61 7 3845 3510
Email 42542 0
Contact person for public queries
Name 42543 0
Dr Michelle Neller
Address 42543 0
QIMR Berghofer Medical Research Institute.
300 Herston Rd
Herston QLD 4006
Country 42543 0
Phone 42543 0
+61-7-3362 0412
Fax 42543 0
+61 7 3845 3510
Email 42543 0
Contact person for scientific queries
Name 42544 0
Prof Rajiv Khanna
Address 42544 0
QIMR Berghofer Medical Research Institute.
300 Herston Rd, Herston QLD 4006
Country 42544 0
Phone 42544 0
+61 7 3362 0385
Fax 42544 0
+61 7 3845 3510
Email 42544 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary