Infusion of donor-derived CMV peptide-specific CTL after allogeneic HSCT

A Phase I clinical trial of infusion of donor-derived HLA-A*0201-restricted CMV pp65 peptide-specific CTL to reconstitute CMV-specific immunity after allogeneic haematopoietic stem cell transplantation.

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000213640

Enrollment

Registered

2005-08-25

Start date

2001-08-01

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

CMV infection or reactivation causes morbidity and mortality in patients after allogeneic HSCT. We aim to adoptively transfer donor-derived CMV-specific CTL to prevent CMV infection and reactivation in these patients.

Interventions

Phase I study of intravenous infusion of monocyte-derived dendritic cell-primed, donor-derived, HLA-A*0201-restricted, CMV pp65 peptide-specific in vitro expanded cytotoxic T lymphocytes on or after day 28 post stem cell infusion.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Inclusion criteria

HLA-A*0201 pos and CMV seropositive donor, 5/6 or 6/6 sib match or 6/6/MUD, GVHD < grade II at the time of infusion, >day 28 post allogeneic HSCT, no recent anti-lymphocyte globulin.

Exclusion criteria

No exclusion criteria

Outcome results