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CD40-L Blockade for Prevention of Acute Graft-Versus-Host Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE1

CD40-L Blockade for Prevention of Acute Graft-Versus-Host Disease

NCT03605927•H. Lee Moffitt Cancer Center and Research Institute

Summary

The purpose of this study is to examine the safety and efficacy of the addition of BMS-986004 to standard of care Sirolimus (SIR)-based immune suppression.

Detailed Description

The approach builds upon extensive evidence supporting the benefit of CD40L blockade in disrupting key signaling events associated with immune activation. The trial addresses a pressing clinical need, namely prevention of Graft-Versus-Host Disease (GVHD) after hematopoietic cell transplantation (HCT) and promotion of donor-recipient immune tolerance. The safety profile of this anti-CD40L antibody overcomes major prior limitations, and the planned biologic studies will provide significant mechanistic insight.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Hematologic malignancy or blood disorder requiring allogeneic HCT
•Adequate vital organ function as defined per protocol
•Karnofsky Performance Status Score (KPS) ≥ 80%
•Participants must have an available 8/8 HLA-A, -B, -C, and -DRB1 matched-related or unrelated donor

Exclusion Criteria

•Active infection not controlled with appropriate antimicrobial therapy
•HIV, hepatitis B or C infection or known history of HIV, hepatitis B or C(all patients will be tested for HIV, hepatitis B and C as part of standard pre-transplant testing, and will be excluded from this trial if positive)
•Anti-thymocyte globulin, or cyclophosphamide administered within 14 days before or planned to receive with HCT conditioning or as part of GVHD prophylaxis in the 14 days after HCT
•Known allergic reactions to components of the study drug
•Concurrent treatment with another investigational drug
•History of thromboembolism, transient ischemic attack, stroke, myocardial infarction within 3 months preceding the transplant, or uncontrolled congestive heart failure or cardiac arrhythmias.

Locations (3)

City of Hope Cancer Center

Duarte, California, United States

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Key Dates

Start Date

February 15, 2019

Primary Completion Date

July 25, 2023

Completion Date

July 25, 2023

Last Updated

January 7, 2026

Enrollment

ACTUAL participants

Conditions

Graft-versus-host-diseaseGVHDGVHD, Acute

Interventions

BMS-986004

DRUG

Sirolimus

DRUG

Tacrolimus

DRUG

A Study to Evaluate Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft-Versus-Host Disease After at Least 2 Prior Lines of Systemic Therapy (AGAVE-256)

NCT07124078

Chronic Graft-versus-host-disease

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RECRUITINGPHASE2

Ruxolitinib vs Prednisone as First-line Therapy for cGVHD Needing Systemic Therapy

NCT06660355

Chronic Graft-versus-host Disease (cGVHD)

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RECRUITINGEARLY_PHASE1

A Clinical Study Evaluating the Safety and Efficacy of GT729 Universal Cell Injection in the Treatment of Refractory or Relapsed Chronic Graft-versus-host Disease (cGVHD)

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 7, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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CD40-L Blockade for Prevention of Acute Graft-Versus-Host Disease

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft-Versus-Host Disease After at Least 2 Prior Lines of Systemic Therapy (AGAVE-256)

Ruxolitinib vs Prednisone as First-line Therapy for cGVHD Needing Systemic Therapy

A Clinical Study Evaluating the Safety and Efficacy of GT729 Universal Cell Injection in the Treatment of Refractory or Relapsed Chronic Graft-versus-host Disease (cGVHD)

SYsteMatical Trained learnIng aLgorithms for Oral carcInogenesiS Interpretation by Optical Coherence Tomography

A Feasibility Study Using CLINIMACS® for Alpha/Beta T-Cell Depletion in Stem Cell Transplant

A Phase II Study Evaluating the Efficacy and Safety of ABSK021 (Pimicotinib)) in the Treatment of cGvHD Chronic Graft Versus Host Disease (cGvHD)