Using donor-derived T-cells to fight viral infections after stem cell transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of donor-derived viral specific T-lymphocytes (VSTs) in preventing or treating viral infections that can occur after an allogeneic stem cell transplant. The study compares two approaches: scheduled administration of VSTs versus treatment administration based on the presence of viral infections. By utilizing VSTs, the trial aims to reduce the complications and costs associated with traditional antiviral treatments, which can be burdensome for patients and their families. The study is designed to assess the safety and efficacy of this innovative approach in a Phase 2 setting.

Why it matters

Who can join: the full rules

SCHEDULED ARM:

Inclusion Criteria:

* Recipient must be at least 21 days after stem cell infusion
* Clinical status must allow tapering of any steroids to \< 0.5mg/kg prednisone or other steroid equivalent
* No critical illness making VST infusion hazardous

Exclusion Criteria:

* Active acute GVHD grades II-IV.
* Uncontrolled relapse of malignancy.
* Infusion of ATG or alemtuzumab within 2 weeks prior to VST infusion. Alemtuzumab levels will be collected in the second week following stem cell infusion in patients who received alemtuzumab as part of their conditioning regimen. The level must be less than or equal to 0.15 prior to infusion of VSTs. In patients with level greater than 0.15, alemtuzumab levels can be checked serially until a level ≤ 0.15 is obtained. They would become eligible for scheduled VST infusion at that point.

TREATMENT ARM

Inclusion Criteria:

* Blood adenovirus PCR ≥1,000
* Blood CMV PCR ≥ 500
* Blood EBV PCR ≥ 9,000
* Plasma BKV PCR \>1,000
* Evidence of invasive adenovirus infection. Adenovirus infection will be defined as the presence of adenoviral positivity as detected by PCR or culture from one site such as stool or blood or urine or nasopharynx. Adenovirus disease will be defined as the presence of adenoviral positivity as detected by culture or PCR from more than 2 sites such as stool or blood or urine or nasopharynx.
* Evidence of invasive CMV infection, defined as pneumonitis, retinitis, colitis, hepatitis
* Evidence of EBV-associated lymphoproliferation (EBV-LPD) defined as proven EBV-LPD by biopsy or probable EBV-LPD defined as an elevated EBV DNA level in the blood associated with clinical symptoms (adenopathy or fever or masses on imaging) but without biopsy confirmation.
* Evidence of symptomatic BK virus infection, defined as hemorrhagic cystitis or BK nephropathy.
* No active acute GVHD grades II-IV
* No uncontrolled relapse of malignancy
* No infusion of ATG or alemtuzumab within 2 weeks of VST infusion.
* Clinical status must allow tapering of any steroids to \< 0.5mg/kg prednisone or other steroid equivalent

Where it's running

• Cincinnati Children's Hospital Medical Center
  Cincinnati, Ohio, United States Recruiting

Study contacts

• Principal investigator: Stella Davies, MBBS, PhD — Children's Hospital Medical Center, Cincinnati
• Study coordinator: Jamie Wilhelm, BS
• Email: Jamie.Wilhelm@cchmc.org
• Phone: 513-803-1102

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.