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

Fred Hutchinson Cancer Center (FHCC)

Status

Conditions: Infection; Precancerous/Nonmalignant Condition

Treatments: Procedure: allogeneic bone marrow transplantation; Radiation: total-body irradiation; Biological: therapeutic allogeneic lymphocytes

Study type: Expanded Access

Funder types: Other; NIH

Identifiers

NCT00547235

FHCRC-2215.00

2215.00

CDR0000570998 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: Under 1 year old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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