CD40-L Blockade for Prevention of Acute Graft-Versus-Host Disease
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.
1. Determine if anti-CD40L antibody therapy in combination with standard sirolimus-based immune suppression prophylaxis significantly reduces the cumulative incidence of grade II-IV acute GVHD after HCT.
1. Determine if anti-CD40L antibody therapy will promote development of donor-recipient immune tolerance, as measured by reduced incidence of chronic GVHD, and successful liberation from immune suppression after HCT.
2. Examine safety of anti-CD40L antibody therapy, as measured by comprehensive study of toxicity and mortality outcomes after HCT.
3. Investigate how anti-CD40L antibody therapy impacts markers of immune activation.
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
Pregnancy or nursing
Known allergic reactions to components of the study agent
Concurrent treatment with another investigational agent
History of thromboembolism, transient ischemic attack, stroke, myocardial infarction within 3 months preceding the transplant, or uncontrolled congestive heart failure or cardiac arrhythmias.
Post-transplant maintenance therapies such as FLT3 inhibitor, tyrosine kinase inhibitor, JAK inhibitors etc. are not allowed if plan is to initiate such therapies <90 days post-transplant. Patient will be eligible if plan to initiate maintenance therapy is after day 90 post-transplant
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