Phase 2 Study BRIDGING PRE-TRANSPLANT INFLAMMATORY DAMPENING for PRIMARY IMMUNE REGULATORY DISORDERS (BRIDGE Trial)

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"

Eligibility

Age range

Not specified

Sex

All

Healthy volunteers

No

Interventions

• Drug
  Emapalumab

  Emapalumab on Days -22 (22 days before the day of the stem cell transplant), -15, -8, and -1.

• Drug
  Fludarabine and Dexamethasone

  Fludarabine and dexamethasone for 5 days in a row on Days -22 through -18.

• Procedure
  Stem Cell Transplant

  Participants in both groups will receive their standard-of-care stem cell transplant on Day 0.

Locations (12)