Overview

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

Status:
Recruiting
Trial end date:
2024-01-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Collaborator:
Bristol-Myers Squibb
Treatments:
Antibodies
Everolimus
Sirolimus
Tacrolimus
Criteria
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.

- 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.