drugset / Trial / NCT05787574
A Study of Treatment of Inflammation Before Stem Cell Transplant in People With a Primary Immune Regulatory Disorder (PIRD) and/or an Autoinflammatory Condition
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The researchers are doing this study to find out whether emapalumab or a combination of fludarabine and dexamethasone are effective in preparing people with a primary immune regulatory disorder (PIRD) and/or an autoinflammatory condition to receive a stem cell transplant. The researchers will look at how well the study treatments reduce inflammation and aid in the engraftment process (the process of donated stem cells traveling to the bone marrow, where they begin to make new immune cells. "Funding Source - FDA OOPD"
Timeline
- Start
- 2023-03-15
- Primary completion
- 2027-03
- Completion
- 2027-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexamethasone | Small molecule | — | — |
| Subject | Emapalumab | Monoclonal antibody | 3 mg/kg | — |
| Subject | Fludarabine | Small molecule | — | — |