Pilot Study in the Treatment of Refractory Adenovirus (ADV) Infection with Related Donor ADV Cytotoxic T-Lymphocytes (ADV-CTLs) in Children, Adolescents and Young Adult Recipients
Phase: Recruiting
First Posted: October
Condition(s): Adenovirus (ADV)
NCT Number: NCT03266627 Other Study ID Number(s): NYMC 579-Adeno
What Is the Purpose of This Study?
The goal of this study is to find out 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's cells or a closely matched family donor and grown in the lab. These immune cells are designed to help fight adenovirus (ADV) infection.
Who Can Take Part in This Study?
- Patients with adenovirus infections after an allogeneic stem cell transplant (HSCT) or those with primary immunodeficiencies, who have:
- Rising adenovirus levels (increased by 10 times) after 7 days, or
- Persistent adenovirus levels after 14 days, despite two weeks of proper anti-viral treatment, and/or
- Ongoing symptoms caused by adenovirus, such as:
- Lung infection (pneumonitis)
- Bladder inflammation with bleeding (hemorrhagic cystitis)
- Colon inflammation (colitis)
- Liver inflammation (hepatitis)
- Inability to 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/NCT03266627
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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