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Treatment of inflammation before stem cell transplant for immune disorders

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

PHASE2 · Memorial Sloan Kettering Cancer Center · NCT05787574

This study is testing if a new treatment can help reduce inflammation in people with immune disorders before they get a stem cell transplant to improve the chances of a successful procedure.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment39 (estimated)
SexAll
SponsorMemorial Sloan Kettering Cancer Center (other)
Drugs / interventionsemapalumab, Fludarabine
Locations12 sites (San Francisco, California and 11 other locations)
Trial IDNCT05787574 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of emapalumab and a combination of fludarabine and dexamethasone in reducing inflammation in patients with primary immune regulatory disorders and autoinflammatory conditions prior to receiving a stem cell transplant. The goal is to enhance the engraftment process, which is crucial for the success of the transplant. Participants will be monitored for their response to these treatments and how well they prepare for the transplant procedure.

Who should consider this trial

Good fit: Ideal candidates include patients undergoing their first allogeneic hematopoietic cell transplant for primary immune regulatory disorders or autoinflammatory conditions with specific inflammatory markers.

Not a fit: Patients with conditions not related to primary immune regulatory disorders or autoinflammatory conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve transplant outcomes for patients with immune disorders by effectively managing inflammation.

How similar studies have performed: Other studies have shown promise in using similar approaches to manage inflammation in transplant settings, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Patients receiving first allo-HCT for the following immunologic conditions:
* Primary Immune Regulatory Disorder with or without a genetic lesion as defined by the Primary Immune Deficiency Treatment Consortium (PIDTC)
* Patients with autoinflammatory disorders evidenced by cytokine or inflammation assays with at least 1.5x ULN of measured cytokines and/or an elevated ferritin or ESR \> 2 ULN
* For inclusion on the emapalumab group, the lesion must be isolated to the IFNγ pathway (or mediators thereof) with an elevated CXCL9 \>1.5 ULN OR sIL2R \>1.5 ULN (or already controlled on immune modulation, provided that CXCL9 or sIL2R levels were elevated prior to initiation of immune modulation). Inclusion on the Fludarabine/dexamethasone group requires inflammation (as defined above) other than an isolated IFNγ pathway
* Able to tolerate cytoreduction (based on adequate organ function as described below)
* Patients of any age can enroll so long as they meet other inclusion criteria:
* Adequate organ function is required, defined as follows:

  * Hepatic: Serum bilirubin ≤ 2 mg/dL, unless benign congenital hyperbilirubinemia. Patients with hyperbilirubinemia related to paroxysmal nocturnal hemoglobinuria or other hemolytic disorders related to their PIRD diagnosis are eligible.
  * Hepatic: AST, ALT, and alkaline phosphatase \< 2.5 times the upper limit of normal unless thought to be disease-related. Investigator will need to perform clinically indicated evaluations to assess if disease related or intrinsic liver disease. Additional testing may be done if clinically indicated, after the pre-transplant immune prophase and prior to start of conditioning as this will provide additional data to confirm disease related versus intrinsic liver dysfunction.
  * Renal: serum creatinine \<1.5x normal for age. If serum creatinine is outside the normal range, then CrCl \> 50 mL/min/1.73m2 (calculated or estimated) or GFR (mL/min/1.72m2) \>30% of predicted normal for age.
  * Normal GFR by Age
  * Cardiac: LVEF ≥ 50% by MUGA or resting echocardiogram.
  * Pulmonary: Pulmonary function testing (FEV1 and corrected DLCO) ≥ 50% predicted (pediatric patients unable to complete PFTs will need oxygen saturation as recorded by pulse oximetry of ≥92% on room air).
* Adequate performance status:

  * Age ≥ 16 years: ECOG ≤ 1 or Karnofsky 70%
  * Age \< 16 years: Lansky 70%
* Each patient must be willing to participate as a research subject and must sign an informed consent form or legal guardian with assent as appropriate.

Exclusion Criteria:

* Uncontrolled infection at the time of enrollment.
* Patients who have undergone previous allo-HCT.
* Patient seropositivity for HIV I/II and/or HTLV I/II.
* Females who are pregnant or breastfeeding.
* Patients unwilling to use contraception during the study period.
* Patient or parent or guardian unable to give informed consent or unable to comply with the treatment protocol including research tests.

Donor Inclusion Criteria:

* Related Donors:

  * 8/8 or 7/8 HLA matched at A, B, C, and DRB1 loci, as tested by DNA analysis.
  * Haploidentical donors at A, B, C and DRB1 loci, as tested by DNA analysis
* Unrelated Donors:

  o 8/8 or 7/8 matched at A, B, C, and DRB1 loci, as tested by DNA analysis.
* Able to provide informed consent for the donation process per institutional standards.
* Meet standard criteria for donor collection (e.g. National Marrow Donor Program Guidelines or collecting center guidelines as approved by treating physician).

Where this trial is running

San Francisco, California and 11 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Primary Immune Regulatory Disorder, Autoimmune Lymphoproliferative, Immune System Diseases, Stem Cell Transplant, Emapalumab, Fludarabine, Dexamethasone, 23-040

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.