This study is for patients that have been diagnosed with Epstein-Barr Virus associated Post-Transplant Lymphoproliferative Disorder (EBV-PTLD). The investigational drug in this study is tabelecleucel. Tabelecleucel is a product containing special immune allogeneic cells, called EBV-Cytotoxic T Lymphocytes (EBV-CTLs), that are made in the laboratory starting with cells from a healthy person who is immune to EBV. The purpose of this study is to test how well tabelecleucel works to treat EBV-PTLD following SOT in patients who have not responded to rituximab or rituximab plus chemotherapy treatment and to see what side effects happen. Your participation will help us to understand more about tabelecleucel. In the first 12-month period, participants will be asked to come to the clinic for an estimated 11 to 19 study visits and a minimum of 2 scans, depending on the number of cycles of treatment they are given. After treatment is done, participants will enter into the follow-up phase, and will continue to come into the clinic for scheduled check-ups for up to 24 months after the first dose of tabelecleucel was given. Participant information on the status of their disease and any new treatment will be collected for up to an additional 3 years. Participants can expect to be in this study for up to five years total.

Subjects in the first group will be enrolled in the GM-CSF for Reversal of Immunoparalysis in Pediatric Sepsis-induced MODS (GRACE-2) trial, comparing GM-CSF versus placebo. Subjects in the second group will be an observational cohort with no intervention, because this group has very low mortality and morbidity. Subjects in the third group will be enrolled in the Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS (TRIPS) trial, comparing anakinra and placebo. The fourth group, with very severe inflammation,
will be an observational cohort because clinical management of the inflammation
is standard of care, and there is no equipoise about enrolling these children in a placebo controlled trial. The primary outcome of both trials will be duration and severity of organ dysfunction using the cumulative PELOD-2 score, and secondary outcomes will assess health related quality of life and family functioning at 3 and 12 months.

Hematopoietic cell transplantation (HCT) and solid organ transplantation (SOT) recipients are at high risk for respiratory viral infection (RVI). This study aims to establish a comprehensive RVI diagnostic and disease progression predictive model in children undergoing HCT and SOT. Findings will result in the first ever evidence-based pediatric guidelines.

This study is an open label, Comparative Effectiveness Research study in patients who receive a heart transplant. Subjects will be enrolled into the study while under evaluation for heart transplantation or on the transplant waiting list prior to heart transplantation. All subjects will follow the center's standard of care surveillance schedule from transplant through 4 weeks post-transplantation. The study objective is to compare the effectiveness of rejection surveillance of heart transplant recipients with Prospera dd-cfDNA to rejection surveillance with endomyocardial biopsy (EMB) in the first post-transplant year.
The Prospera™ test is a non-invasive test intended to detect and quantify the fraction of donor-derived cell-free DNA (dd-cfDNA) to supplement management and surveillance of allograft rejection in patients who have undergone organ transplantation. The subjects may undergo blood draws, echocardiogrphys, medical history and physical exams, antibody testing, nuclear imaging, and MRI as apart of the study. The study period will be during the first 12 months post-transplant. Quality of life questionnaires will be completed at week 4, month 6 and month 12 post-transplant.

Examine current real-world utilization of mcfDNA using a multi-center retrospective registry. To achieve this aim, we will utilize a multi-center REDCap database to examine and summarize patient demographics and types of transplants where mcfDNA was used. We will classify cases based on common syndromes/indications for which mcfDNA is sent, timing of the test, and clinically relevant microbiologic yield of mcfDNA results.

Identify clinical predictors where mcfDNA outperforms CMT. We will analyze specific clinical syndromes where mcfDNA has higher yield compared to CMT including pneumonia, visceral abscesses, CNS infections, etc. We will also
identify specific pathogens that are more likely to be detected by mcfDNA earlier in the clinical course such as bartonella, syphilis, parasitic infections, and other atypical bacteria, mycobacteria, and fungi.

Analyze clinical impact of mcfDNA to assess whether the use of the test had a positive vs. negative vs. neutral impact on patient care using pre-specified definitions. Additionally, we will perform clinical adjudication of positive and
negative mcfDNA cases using standardized criteria and analyze effect of timing of test ordering on clinical impact.

The long-term objective of this proposed R24 program is to enhance our understanding of how circadian rhythm disruption contributes to vulnerability to alcohol-induced organ damage, and to explore the underlying mechanisms (e.g. microbiota) that could lead to the identification of novel therapeutic targets. This knowledge aims to inform the development of innovative strategies to prevent and to treat alcohol-related pathologies.

The purpose of this study is to test the safety of NXC-201 at different doses in participants with relapsed/refractory AL amyloidosis, and to confirm the best dose for further testing. In addition, the study will evaluate the effectiveness of NXC-201 in treating relapsed/refractory AL amyloidosis.

AL amyloidosis is a rare systemic disorder caused by an abnormality of plasma cells (a type of white blood cell that is part of the immune system) in the bone marrow. Misfolded proteins produced by these cells can build up in and around tissues, nerves and organs, gradually affecting their function. This can cause progressive and widespread organ damage.

NXC-201 is made using a person's own T Cells (immune system cells that protect the body from infections, cancer, and other possible harms). The T cells are collected then genetically modified (changes are made to the DNA or genes) outside of the body in a laboratory. A virus is used to introduce a gene that creates a protein (called a chimeric antigen receptor or CAR) on the surface of T cells. The virus then becomes inactive. The changes are designed to help the NXC-201 cells find and destroy plasma cells that have a protein on their surface called B-cell maturation antigen (BCMA). T-cell therapies like NXC-201 are called CAR T-cell therapies. After being reinjected, the CAR-T cells multiply and spread throughout the body.

NXC-201 is an investigational "treatment", which means it has not been approved by the US Food and Drug Administration (FDA) for the treatment of AL Amyloidosis or any other disease.

Calling the study drug a "treatment" in this consent form does not indicate that it will be effective in treating your AL Amyloidosis.

Before receiving NXC-201, participants will receive lymphodepleting chemotherapy (or lymphodepletion) with cyclophosphamide and fludarabine to briefly weaken (suppress) your immune system. The lymphodepletion will help prepare the body for receiving NXC-201. Cyclophosphamide and fludarabine are FDA-approved for use as lymphodepleting chemotherapy.

This study is sponsored by Nexcella, Inc., which is responsible for funding and organizing the study.