Skip to content

Emergency Use of Adoptive Immunotherapy With CMV-Specific T Cells After Donor Bone Marrow Transplant of an Infant With Immunodeficiency Syndrome and CMV Infection

Protocol For The Emergency Use Of Adoptive Immunotherapy With CMV-Specific T Cells Following HLA-Matched Unrelated Donor Bone Marrow Transplant Of An Infant With ADA-SCIDs And Pre Transplant CMV Infection

Status
NO_LONGER_AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT00547235
Enrollment
Unknown
Registered
2007-10-22
Start date
2007-09-30
Completion date
Unknown
Last updated
2010-08-24

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

Conditions

Infection, Precancerous/Nonmalignant Condition

Keywords

infection, precancerous/nonmalignant condition

Brief summary

RATIONALE: Collecting the T cells from a donor and transplanting them into a patient may be effective treatment for immunodeficiency syndrome and CMV infection. PURPOSE: This clinical trial is studying the emergency use of adoptive immunotherapy with CMV-specific T cells after donor bone marrow transplant of an infant with immunodeficiency syndrome and CMV infection.

Detailed description

OBJECTIVES: * To determine if adoptive immunotherapy with donor-derived CD4+ and CD8+ CMV- specific cytotoxic lymphocyte cell lines can augment T-cell immunity and treat CMV infection post transplant in a patient with severe combined immunodeficiency syndrome. OUTLINE: The patient will undergo HLA-matched unrelated donor bone marrow transplantation from a CMV-seropositive donor after undergoing conditioning with 200cGy total-body irradiation per protocol FHCRC Protocol 1227. CD8-positive and CD4-positive CMV-specific T cells are collected from the donor and used to generate T-cell lines. If the patient has progressive or persistent CMV infection, then she will receive donor T cells IV over 30 minutes. Infusions may be repeated after at least 14 days if the previous infusion was well tolerated and if the CMV infection is persistent or increasing. The patient undergoes blood sample collection at baseline and 7 days after T-cell infusion to assess CMV-specific T-cell response.

Interventions

BIOLOGICALtherapeutic allogeneic lymphocytes
PROCEDUREallogeneic bone marrow transplantation
RADIATIONtotal-body irradiation

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Fred Hutchinson Cancer Center
Lead SponsorOTHER

Eligibility

Sex/Gender
FEMALE
Age
No minimum to 1 Years
Healthy volunteers
No

Inclusion criteria

DISEASE CHARACTERISTICS: * Adenosine deaminase-deficient severe combined immunodeficiency syndrome (ADA-SCIDs) * CMV interstitial pneumonia based on the constellation of clinical and radiological findings PATIENT CHARACTERISTICS: * Female * Oxygen desaturation (pulse oximetry 85% on room air) * Abnormal chest radiograph * No CMV retinitis PRIOR CONCURRENT THERAPY: * Prior ganciclovir and foscarnet sodium

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026