A Pilot Study on Treating Resistant Epstein-Barr Virus (EBV) Infections in Children, Adolescents, and Young Adults Using Donor Immune Cells Specifically Targeting EBV
Phase: Recruiting
First Posted: October
Condition(s): Epstein Barr Virus (EBV)
NCT Number: NCT03266653 Other Study ID Number(s): NYMC 581-EBV
What Is the Purpose of This Study?
The goal of this study is to see if we can safely give the patient special immune cells called cytotoxic T-cells (CTLs). These cells are made from the patient’s stem cell donor or a closely matched family donor and grown in the lab. These immune cells are designed to help fight Epstein-Barr Virus (EBV) infection.
Who Can Take Part in This Study?
- Patients with Epstein-Barr virus (EBV) infections after receiving an allogeneic stem cell transplant (HSCT), or
- Patients with rising EBV levels (increased by 10 times) in their blood after 7 days, or
- Patients with persistent EBV levels after 14 days, despite two weeks of proper anti-viral treatment, and/or
- Patients showing worsening symptoms related to EBV, such as:
- Biopsy-confirmed colitis (inflammation of the colon)
- Swollen lymph nodes (lymphadenopathy)
- Enlarged liver (hepatomegaly)
- Enlarged spleen (splenomegaly)
- Patients who cannot tolerate anti-viral treatments due to side effects
- Age: 0.1 to 30.99 years
For a full list of eligibility requirements, visit https://clinicaltrials.gov/study/NCT03266653
What Will Happen During This Study?
- Patients will receive up to 5 infusions of CTLs.
- The infusions will be given every 2 weeks.
- Before, during and after treatment with the CTLs, they will have blood labs and assessments completed over multiple visits.
Principal Investigator
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