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Life sciences · Phase EARLY_PHASE1 Trial
ClinicalTrials.gov · October 14, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase EARLY_PHASE1 Trial.
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Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT07873970). This is a study registration, not published results. Lead sponsor: Children's Hospital of Philadelphia. Recruitment status: NOT_YET_RECRUITING. Phase: EARLY_PHASE1. Study type: INTERVENTIONAL. Enrollment: 35 participants (ESTIMATED). Conditions: EBV Viremia, CMV Viremia, BK Viremia, Adenovirus, Post-transplant Lymphoproliferative Disorder, Viremia, Cytomegalovirus Enteritis, Adenovirus Infection, Epstein-Barr Virus Infection Reactivation, Epstein Barr Virus Infection, BK Virus Infection, Refractory Viral Infection, Opportunistic Viral Infection, Primary Immunodeficiency, Severe Combined Immunodeficiency (SCID), Inherited Immunodeficiency Diseases, Acquired Immunodeficiency, Stem Cell Transplant Complications, Solid Organ Transplant Complications. Interventions: BIOLOGICAL: Virus-Specific Cytotoxic T Lymphocytes (vCTLs). Primary outcome measures: Occurrence of Grade 3 or higher acute graft-versus-host disease (GVHD) , From first vCTL infusion (Day 0) through 12 weeks after the final vCTL infusion; Occurrence of Grade 3 or higher infusion-related reactions , From first vCTL infusion (Day 0) through 12 weeks after the final vCTL infusion. Brief summary: This study is evaluating the safety and effectiveness of virus-specific cytotoxic T lymphocytes (vCTLs) for treating difficult-to-control viral infections caused by cytomegalovirus (CMV), adenovirus (ADV), Epstein-Barr virus (EBV), or BK virus in children, adolescents, and young adults with weakened immune systems. Eligible participants include recipients of hematopoietic stem cell transplantation, solid organ transplantation, and patients with primary immunodeficiency disorders. vCTLs are immune cells collected from a related donor and selected to recognize and fight specific viruses. The cells are manufactured using the CliniMACS® Cytokine Capture System and administered by intravenous infusion. Additional infusions may be given if viral infection persists. The study will assess the safety of vCTL therapy, including the risk of graft-versus-host disease (GVHD) and infusion-related reactions, as well as its ability to reduce viral infection, improve clinical outcomes, and support survival. Participants will be monitored for approximately 12 weeks after their final vCTL infusion. Participants will all receive vCTLs; there is no comparison group. Participants will: 1. Have donor-derived vCTLs manufactured for infusion using the CliniMACS Cytokine Capture System 2. Receive the vCTLs through an intravenous infusion 3. Be monitored for side effects and infusion reactions, viral levels through blood testing, clinical outcomes, including response to treatment, survival, and time without detectable virus