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Immunosuppressant

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

Phase 1
Waitlist Available
Led By Farhad Khimani, M.D.
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year post hct
Awards & highlights
No Placebo-Only Group

Summary

This trial will study whether the addition of BMS-986004 to standard of care Sirolimus-based immunosuppression is safe and effective.

Eligible Conditions
  • Graft-versus-Host Disease
  • Acute Graft-versus-Host Disease
  • GVHD

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year post hct
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year post hct for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of Grade II-IV Acute Graft-versus Host Disease
Secondary study objectives
Chronic Graft-versus Host Disease Through 1 Year Post HCT
Malignancy Relapse Post-HCT
Non-relapse Mortality
+1 more
Other study objectives
Glucocorticoid Exposure
Neutrophil and Platelet Engraftment

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Combination TherapyExperimental Treatment3 Interventions
BMS-986004: From day 13, intravenously (IV) every 2 week through day 100 post HCT. Tacrolimus: From day -3 as standard of care. Sirolimus: From day -1 as standard of care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tacrolimus
2019
Completed Phase 4
~5510
Sirolimus
2013
Completed Phase 4
~2750
BMS-986004
2019
Completed Phase 1
~50

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
567 Previous Clinical Trials
144,874 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,696 Previous Clinical Trials
4,099,026 Total Patients Enrolled
Farhad Khimani, M.D.Principal InvestigatorH. Lee Moffitt Cancer Center and Research Institute
~7 spots leftby Jan 2026
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