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A Study of Treatment of Inflammation Before Stem Cell Transplant in People With a Primary Immune Regulatory Disorder (PIRD) and/or an Autoinflammatory Condition

NCT05787574 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2025-10-29

No results posted yet for this study

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"

Conditions

  • Primary Immune Regulatory Disorder
  • Autoimmune Lymphoproliferative
  • Immune System Diseases

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.

Sponsors & Collaborators

Principal Investigators

  • Andromachi Scaradavou, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-15
Primary Completion
2027-03-31
Completion
2027-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05787574 on ClinicalTrials.gov