Pilot Study of Darzalex Faspro Injection Before Desensitization and Blood Stem Cell Transplant in Adults at High Risk of Graft Failure from Donor Antibodies

What this Trial Is About

Researchers are evaluating Darzalex Faspro daratumumab and hyaluronidase-fihj, a monoclonal antibody targeting plasma cells, to determine its safety and ability to reduce donor-specific antibody DSA levels in adult patients with high DSA who are at risk of rejecting donor blood stem cells during allogeneic peripheral blood stem cell transplantation alloBMT. This study is a pilot trial conducted at Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, focusing on patients with relapsed or refractory hematologic malignancies where high DSA levels increase the risk of primary graft failure PGF. Participants will receive four weekly subcutaneous doses of Darzalex Faspro, each at 1800 mg, given on Days -42, -35, -28, and -21 before transplantation. After this treatment, they will undergo a standard desensitization regimen including therapeutic plasma exchange TPE, intravenous immunoglobulin IVIG, and immunosuppression, followed by the alloBMT procedure. The study uses a proprietary scoring system JH-DSA Semi-Quant Screen Score to select patients and to evaluate response to treatment. During the study, researchers will monitor DSA levels to assess efficacy and track safety by recording any grade 3 or higher toxicities over two years. Secondary outcomes include time to neutrophil and platelet recovery, T-cell chimerism achievement, and occurrence of primary graft failure. Participants will be regularly assessed with laboratory tests and clinical evaluations throughout the treatment and follow-up periods to determine treatment effects and safety.

Darzalex Faspro (Daratumumab and Hyaluronidase-fihj) Before Standard Desensitization and Allogeneic Peripheral Blood Stem Cell Transplantation in Adult Patients at High-risk for Primary Graft Failure Secondary to Donor Specific Antibodies