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Adoptive Cord Blood Immunotherapy for Viral Infections

This study is testing a treatment called CMV/AdV/EBV/BKV specific T cells. These are special immune cells from umbilical cord blood that help fight common viruses like CMV, Adenovirus (AdV), Epstein-Barr virus (EBV), and BK virus (BKV). The study aims to find the safest and most effective dose of these cells for patients who have had a transplant and are at risk for or have these viral infections. Both children and adults who are candidates for a transplant and have a matching cord blood unit can join. The main goal is to see how many participants experience side effects from the treatment. The current status of this study is unclear.

Study design
This is a Phase I-II dose-finding study involving up to 36 participants. Participants will be treated in small groups of two, with the dose of T cells gradually increased based on how well it's tolerated.
What's involved
Each group of two patients will receive the treatment and be watched for 45 days to check for side effects and how well they tolerate the dose.
Compensation
Not stated in the trial record.
Follow-up
Participants will be observed for 45 days after treatment to assess for side effects.

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NCT03594981

Adoptive Cord Blood Immunotherapy for EBV, CMV, BKV and Adenovirus Reactivation/Infection or Prophylaxis

Active, Not Recruiting
PHASE1All AgesInterventionalTreatment
Catherine Bollard
~2 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:CMV/AdV /EBV/BKV specific T cells

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with investigational product-related adverse events as assessed by CTCAE v4.03
Measured over 45 days for toxicity

Conditions

Viral Infection

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Viral Infection

Where it's being run

2 sites across 2 states
District of Columbia1
Texas1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Pediatric and adult patients (there are no lower and upper age limits for patients) with malignant or nonmalignant diseases who are candidates for transplant.
Patients must have a CB unit (or units) matched with the patient at 4, 5, or 6/6 HLA class I (serological) and II (molecular) antigens. The unit selected for CTL expansion must be either:
Recipients of at least one unmanipulated cord blood unit as described above (i.e. from a HLA matched or mismatched unrelated donor) transplant at risk for or with CMV/Adenoviral/BKV and/or EBV infection or reactivation.
Lansky/Karnofsky scores ≥60
Absolute neutrophil count (ANC) greater than 500/u
No evidence of GVHD \> Grade II at time of enrollment
Life expectancy \> 30 days
Absence of severe renal disease (Creatinine \< 3x normal for age)
Absence of severe hepatic disease. Direct bilirubin must be \< 3 mg/dl and AST \< 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

Exclusion

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
Pregnant or lactating
Patient on Fi02 of \>60%
Unable to wean steroids to ≤0.5 mg/kg/day prednisone or equivalent
Patients with Grade 3 hyperbilirubinemia
Patients with other uncontrolled infections (except CMV and/or adenovirus and/or EBVemia and/or BK viruria/viremia). 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
Patients who have received investigational (IND) product within 28 days of screening for CTL infusion under this study

What this trial measures

  • Number of participants with investigational product-related adverse events as assessed by CTCAE v4.0345 days for toxicity

    The study will determine the optimal dose of intravenous injection of donor-derived cytotoxic T lymphocytes (CTLs) specific for CMV, EBV, Adenovirus and BK virus( BKV) given to patients with or at risk for CMV, EBV, BK virus and adenovirus infection after cord blood transplant. The safety will be assessed by investigational product-related adverse events as per CTCAE v4.03.