Clinical Research Directory

25BT056: Basket Study of Viral Cytotoxic T Lymphocytes

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

Shwachman-Diamond Syndrome Global Patient Survey and Partnering Platform

The Shwachman-Diamond Syndrome Global Patient Survey and Collaboration Program (SDS-GPS) is an opportunity for patients and their families - from anywhere in the world - to share their experience living with SDS via a safe, secure, and convenient online platform, to * expand the understanding of SDS * improve the lives of people with SDS, and * accelerate the development of new therapies and cures for SDS. By joining, participants will receive early access to relevant information about new clinical trials and other research opportunities (such as clinical registries) based on their profile, accelerating research and increasing clinical trial impact and recruitment success. The platform, consent forms, and surveys are available in five languages: English, Spanish, French, German, and Italian. More languages to come.