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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000981729

Acronym

Nil

Enrollment

Registered

2013-09-03

Start date

2014-06-25

Completion date

2017-07-17

Last updated

2023-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Healthy volunteers

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

Outcome results