Safety, Toxicity and MTD of One Intravenous IV Injection of Donor CTLs Specific for CMV and Adenovirus

Completed · Phase 1

Conditions studied: Cytomegalovirus Infection, Adenovirus Infection

In brief

With this study, we want to see if we can use a kind of white blood cell called T cells to prevent or treat AdV and CMV infection. We will grow these T cells from the cord blood before the patients transplant. These cells have been trained to attack adenovirus/CMV-infected cells and are called Adenoviral/CMV-specific cytotoxic (killer) T-cells or "AdV/CMV-CTL." We would plan to give the patient one dose of AdV/CMV-CTL any time from 30 days after their transplant. We have used T cells made in this way from the blood of donors to prevent infections in patients who are getting a bone marrow or blood stem cell transplant but this will be the first time we make them from cord blood.

Key facts

Study ID: NCT00880789
Run by: Baylor College of Medicine
People needed: 9
Starts: 2009-05-01
Expected to finish: 2014-06-01
Last updated by the study team: 2014-10-15

Who can join

Age: any, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Inclusion criteria at the time of Procurement:
Patient with malignant or nonmalignant diseases who are candidates for transplant.
Patients must have a single CB unit matched with the patient at 4, 5, or 6/6 HLA class I (serological) and II (molecular) antigens. The unit must be cryopreserved in two fractions, with a minimum of 2.5x10\^7 total nucleated cells per kg pre-thaw in the fraction which will be used for the primary transplant. The remaining fraction will be used to generate the CTLs to give at day 30 or beyond as described below.
Inclusion criteria at the time of CTL infusion:
Recipients of a single cord blood unit fractionated into 2 fractions (i.e. from a HLA matched or mismatched unrelated donor) transplant at risk for or with CMV/Adenoviral disease or reactivation.
Lansky/Karnofsky scores 60 or greater
Absolute neutrophil count (ANC) greater than 500/ul.
No evidence of GVHD > Grade II at time of enrollment.
Life expectancy > 30 days
Absence of severe renal disease (Creatinine > x 3 normal for age)
Absence of severe hepatic disease. Direct bilirubin must be less than 3 mg/dl and AST less than 5x upper limit of normal
Patient must be at least 30 days post transplant to be eligible to receive CTL
Written informed consent and/or signed assent line from patient, parent or guardian.
Patient not on Fi02 of >60%

You may not qualify if…

Exclusion criteria at the time of Procurement:
Pregnant or Lactating
Patients with active central nervous system disease
Patients with Karnofsky performance status <70%
Patients with grade 3 or 4 or primary myelofibrosis
Patients with suitable related donors
Exclusion criteria at the time of CTL infusion:
Pregnant or lactating
Unable to wean steroids to 0.5 mg/kg/day or less prednisone.
Patients with other uncontrolled infections (except CMV and/or adenovirus and/or EBVemia in absence of PTLD). For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment. For fungal infections patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment. Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
Patients with less than 50% donor chimerism in either peripheral blood or bone marrow or patients with relapse of original disease.

Where it is running

Houston Methodist Hospital — Houston, Texas, United States
Texas Children's Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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