A phase 1 clinical trial of peptide-pulsed monocyte-derived dendritic cell vaccination to expand adoptively transferred cytomegalovirus -specific cytotoxic T lymphocytes after allogeneic stem cell transplantation

A phase 1 clinical trial of peptide-pulsed monocyte-derived dendritic cell vaccination to expand adoptively transferred CMV-specific cytotoxic T lymphocytes after allogeneic stem cell transplantation

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000458336

Enrollment

Registered

2008-09-15

Start date

2012-08-07

Completion date

2014-03-31

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

A preliminary study of the use of immune cells from transplant donors to prevent cytomegalovirus infection in recipients of blood stem cell transplants. The study hypothesis is that stimulation of infused CMV specific lymphocytes by CMV peptide pulsed DC given as a vaccine will enhance immune reconstitution. The study will use two different sorts of immune cells (called T lymphocytes and dendritic cells). These cells will be prepared in the laboratory and given back to patients after transplant to try to prevent diseases caused by the CMV virus.

Interventions

Donor derived dendritic cells (DC) pulsed with cytomegalovirus (CMV) antigen and/or CMV antigen specific T cells will be injected into patients following haemopoietic stem cell transplantation. There will be 3 arms: Arm 1 - CMV cytotoxic T lymphocyte (CTL) infusion only; Arm 2 - DC vaccine with CMV cytotoxic T lymohocyte infusion; Arm 3 - DC vaccination only. Doses are: CMV cytotoxic T lymphocytes - 2x10^7 per square metre of body surface area once post transplant DC vaccine - 2x10^6 per sqaure

Study design

Allocation

Non-randomised trial

Intervention model

Other

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Inclusion criteria

Recipient and donor pairs with haemopoietic stem cell transplant Human Leukocyte Antigen (HLA)-A2 positive CMV seropositive donor Fully HLA-matched or one antigen mismatched allogeneic transplant

Exclusion criteria

HLA-A2 negative or CMV seronegative donor

Outcome results