Adoptive immunotherapy for the prevention of Human Cytomegalovirus (HCMV) reactivation and disease after Allogenic Stem Cell Transplantation

A phase I/II study to evaluate the effect of a single dose of human Cytomegalovirus (HCMV)-specific bulk cytotoxic T lymphocytes (CTL) to prevent complications associated with HCMV reactivation following allogeneic stem cell transplantation

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000452695

Acronym

QR2002-CMV1

Enrollment

Registered

2005-09-21

Start date

2002-06-30

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

Since the inception of human organ transplantation, HCMV remains single most-important cause of infectious morbidity and mortality in immunocompromised transplant patients. This project is designed to develop immunotherapeutic strategies based on adoptve transfer of virus-specific killer T cells for the treatment of HCMV infection in transplant patients.

Interventions

Donor-expanded bulk HCMV-specific CTL at a single dose on four occasions at monthly intervals, then monthly for 1 year.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Inclusion criteria

Consenting seropositive stem cell donors and recipients, Seropositive stem cell recipients; Without severe intercurrent illness/infection requiring inpatient care, <3x upper normal bilirubin, Creatinine clearance >35% normal for age, Availability of well-characterised HCMV-specific CTL with minimal detectable anti-host alloreactivity.

Exclusion criteria

Active intercurrent infection requiring inpatient care, Laboratory evidence of active CMV infection prior to 1st CTL infusion, ECOG status >3, Positive serology for HIV, Hep B or Hep C.

Outcome results