Official websites use .gov

A .gov website belongs to an official government organization in the United States.

Secure .gov websites use HTTPS

A lock ( 🔒 ) or https:// means you've safely connected to the .gov website. Share sensitive information only on official, secure websites.

Need Help

Phase 2 Bridging Pre-transplant Inflammatory Dampening for Primary Immune Regulatory Disorders (BRIDGE Trial)

Award Number: R01FD007829
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/03/2025
PERIOD OF PERFORMANCE END DATE: 05/31/2028

Group Awards By:

View Award Description

Phase 2 Bridging Pre-transplant Inflammatory Dampening for Primary Immune Regulatory Disorders (BRIDGE Trial) - The Primary Immune Regulatory Disorders (PIRDs) are a group of inborn errors of immunity (IEI) that result from constitutive activation and/or dysregulation of specific immune pathways. There are 130 genes identified to date that are associated with PIRDs. Each PIRD is extremely rare and the PIRDs in general comprise approximately 5% of IEI. Patients with PIRDs often have multiple life-threatening opportunistic infections, autoinflammatory conditions and autoimmune sequelae related to the constant activation of their immune system. Given the rarity of each PIRD, and of PIRDs in general, there are few if any therapeutic interventions for these patients. Hematopoietic Stem Cell Transplant (HCT) offers a curative option for many patients with PIRDs. The high levels of inflammatory mediators in patients with PIRDs however has made it extremely difficult to have successful outcomes due mostly to graft failure/rejection as well as post-transplant immune complications. Patients with PIRDs therefore have limited therapeutic options and only those that are most severely affected are considered for cures with HCT. The BRIDGE Trial is a Phase 2 clinical trial to improve outcomes of curative therapy with HCT for patients with a PIRD diagnosis. The protocol utilizes a biomarker-guided immune suppression prophase to dampen the inflammatory milieu prior to and during a myeloablative conditioning regimen for HCT. Patients may also receive targeted inflammatory suppression regimens to balanced milieu while they are receiving conditioning and to enable more efficient engraftment, balanced immune reconstitution, and improved outcomes:  Patients with PIRDs that result in perturbations of their IFNγ pathway will receive a prophase of an IFNγ neutralizing monoclonal antibody called emapulamab prior to and during the conditioning regimen. Emapalumab is an orphan drug approved for primary hemophagocytic lymphohistiocytosis (pHLH).  Patients with PIRDs that result in dysregulation of other inflammatory pathways will receive a generalized inflammatory suppression prophase with fludarabine and dexamethasone, similar to what is currently being used for patients with hemoglobinopathies undergoing HCT. The dataset produced by this trial will be pivotal to expand indications for emaplaumab. The trial will provide critical data for continued future clinical trials to provide durable cures to patients with PIRD diagnoses. We take advantage of our expertise in immune reconstitution and biomarker discovery studies to provide in- depth correlative biology. Our focus centers on deep immunophenotyping of reconstituting subsets, identification of soluble biomarkers for immune mediated complications, and on identifying mechanisms of how a targeted immune suppression prophase helps provide an appropriate immune milieu during conditioning and as the hematopoietic system regenerates after HCT.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $0 )
2026	2024	THE TRUSTEES OF COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK	630 W 168TH ST FL 4	NEW YORK	NY	10032	NEW YORK	USA	Food and Drug Administration Research	001	3	5/19/2026	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$647,533
2026	2024	SLOAN-KETTERING INSTITUTE FOR CANCER RESEARCH	1275 YORK AVE	NEW YORK	NY	10065	NEW YORK	USA	Food and Drug Administration Research	000	2	3/26/2026	NON-COMPETING CONTINUATION	-$647,533
2026	2024	THE TRUSTEES OF COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK	630 W 168TH ST FL 4	NEW YORK	NY	10032	NEW YORK	USA	Food and Drug Administration Research	002	3	6/2/2026	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2024	SLOAN-KETTERING INSTITUTE FOR CANCER RESEARCH	1275 YORK AVE	NEW YORK	NY	10065	NEW YORK	USA	Food and Drug Administration Research	000	2	8/18/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $647,533 )
2024	2024	SLOAN-KETTERING INSTITUTE FOR CANCER RESEARCH	1275 YORK AVENUE	NEW YORK	NY	10065	NEW YORK	USA	Food and Drug Administration Research	001	2	6/10/2024	NON-COMPETING CONTINUATION	$647,533
2024	2023	SLOAN-KETTERING INSTITUTE FOR CANCER RESEARCH	1275 YORK AVENUE	NEW YORK	NY	10065	NEW YORK	USA	Food and Drug Administration Research	000	1	10/25/2023	NEW	$0
														Subtotal = $647,533

Issue Date FY: 2023 ( Subtotal = $648,109 )
2023	2023	SLOAN-KETTERING INSTITUTE FOR CANCER RESEARCH	1275 YORK AVENUE	NEW YORK	NY	10065	NEW YORK	USA	Food and Drug Administration Research	000	1	9/20/2023	NEW	$648,109
														Subtotal = $648,109

Grand Total All Awards = $1,295,642

Top

All Categories

About

Search

Reports

Data Submission

Award Information

Phase 2 Bridging Pre-transplant Inflammatory Dampening for Primary Immune Regulatory Disorders (BRIDGE Trial)

Award Number: R01FD007829

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/03/2025

PERIOD OF PERFORMANCE END DATE: 05/31/2028

Federal Websites

Department of Health & Human Services

HHS Operating Divisions

HHS Staff Divisions

Download A Document Viewer