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RECRUITING Phase 2

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 · View on ClinicalTrials.gov ↗

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"

Interventions

  • DRUG Emapalumab
  • DRUG Fludarabine and Dexamethasone
  • PROCEDURE Stem Cell Transplant

Study Locations (12)

New York

  • Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) — Commack
  • Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison
  • Memorial Sloan Kettering Cancer Center — New York
  • Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Rockville Centre

New Jersey

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge
  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown
  • Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale

California

  • University of California, San Francisco (Data collection only) — San Francisco

Georgia

  • Children's Healthcare of Atlanta (Data Collection Only) — Atlanta

Pennsylvania

  • Children's Hospital of Philadelphia (Data Collection Only) — Philadelphia

Texas

  • Texas Children's Hospital (Data Collection) — Houston

Wisconsin

  • Children's Hospital of Wisconsin (Data Collection Only) — Milwaukee

Trial Details

FieldValue
Enrollment Target 39 participants
Start Date 2023-03-15
Est. Completion 2027-03
Phase Phase 2

Sponsor

Memorial Sloan Kettering Cancer Center

2,280 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05787574

The ClinicalTrials.gov registry entry for NCT05787574 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Memorial Sloan Kettering Cancer Center, which has 2,280 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Immune System Diseases appearing as the primary indexed condition, and to 3 interventions — of which Emapalumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05787574 reports 12 study locations spanning 7 distinct geographic areas — top geographies include New York, New Jersey, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05787574 about?

NCT05787574 is a clinical study titled "A Study of Treatment of Inflammation Before Stem Cell Transplant in People With a Primary Immune Regulatory Disorder (PIRD) and/or an Autoinflammatory Condition". 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 a...

What is the current status of trial NCT05787574?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2023-03-15. Estimated completion is 2027-03.

What conditions does trial NCT05787574 study?

This clinical trial studies the following conditions: Immune System Diseases, Autoimmune Lymphoproliferative, Primary Immune Regulatory Disorder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05787574?

The interventions under investigation include: Emapalumab (DRUG), Fludarabine and Dexamethasone (DRUG), Stem Cell Transplant (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05787574?

This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 2,280 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05787574 being conducted?

This trial has 12 study locations across California, Georgia, New Jersey, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial