The Center for Cancer and Immunology Research at Children’s National Hospital and the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) formed a partnership in 2017 to develop and conduct collaborative clinical research studies focused on young children with allergic, immunologic, infectious and inflammatory diseases. On an annual basis they host a symposium to exchange their latest research findings.  This year Catherine Bollard, M.B.Ch.B., MD director of the Center for Cancer and Immunology Research t Children’s National and research author presented findings at the symposium held Nov. 8, 2019.  The researchers find tailored T-cells specially designed to combinate a half dozen viruses are safe and may be effective in preventing and treating viral infections.

The Study: Cell Therapy Opportunity to Fight Immune Deficiency Disease

More than 200 forms of primary immune deficiency diseases impact about 500,000 people in America alone. These rare, genetic diseases so impair the person’s immune system that they experience repeated and sometimes rare infections that can threaten lives. After a hematopoietic stem cell transplantation, brand new stem cells can rebuild the person’s missing or impaired immune system. However, while the immune system is in the rebuilding process, the patient can be susceptible to a host of viral infections.

The research team articulates that because viral infections can be controlled by T-cells, the body’s infection-fighting white blood cells, the Children’s National first-in-humans Phase I dose escalation trial aimed to determine the safety of T-cells with antiviral activity against a half dozen opportunistic viruses including: adenovirus, BK virus, cytomegalovirus (CMV), Epstein-Barr virus (EBV), Human Herpesvirus 6 and human parainfluenza-3 (HPIV3).

In the study eight patients received the hexa-valent, virus-specific T-cells after their stem cell transplants:

  • Three patients were treated for active CMV, and the T-cells resolved their viremia
  • Two patients treated for active BK virus had completion symptom resolution, while one had hemorrhagic cystitis resolved but had fluctuating viral loads in their blood and urine
  • Of two patients treated prophylactically, one developed EBV viremia that was treated with rituximab

Two additional patients received the T-cell treatments that under expanded access for emergency treatment, one for disseminated adenoviremia and the other for HPIV3 pneumonia. While these critically ill patients had partial clinical improvement, they were being treated with steroids which may have dampened their antiviral responses.

Comment on Study Safety

Michael Keller, MD, a pediatric immunologist at Children’s National and the study’s lead author noted, “These preliminary results show that hexaviral-specific, virus-specific T-cells are safe and may be effective in preventing and treating multiple viral infections.” He continued, “Of note, enzyme-linked immune absorbent spot assays showed evidence of antiviral T-cell activity by three months post infusion in three of four patients who could be evaluated and expansion was detectable in two patients.”

Lead Research/investigators

Catherine Bollard, M.B.Ch.B., MD director of the Center for Cancer and Immunology Research t Children’s National

Michael Keller, MD, a pediatric immunologist at Children’s National

Katherine Harris, MD

Patrick J. Hanley, PhD, assistant professor in the Center for Cancer and Immunology

Allistair Abraham, MD (blood marrow specialist)

Blachy J. Davilla Saldana, MD, Division of Blood and Marrow Transplantation

Other authors and their presentation titles can be viewed by selecting the source link at the bottom.

Call to Action: These early-stage studies show promise for a new classes of tailored T-cell-based treatments for rare viruses. Early studies reveal that may be safe and effective. This has significant implications. The researchers involved with this study will be important contributors to ongoing research in this field. TrialSite News will monitor their activity. Sign up for the Daily Digest for updates.

Source: EurekAlert!

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