OncoMatch/Clinical Trials/NCT06398457
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
Is NCT06398457 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies multiple treatments including Darzalex Faspro (Daratumumab and hyaluronidase-fihj) and JH-DSA Semi-Quant Screen and Response Score for hematologic malignancy.
Treatment: Darzalex Faspro (Daratumumab and hyaluronidase-fihj) · JH-DSA Semi-Quant Screen and Response Score — This research is being done to investigate the safety and effectiveness of Darzalex Faspro (daratumumab and hyaluronidase-fihj) (a monoclonal antibody that targets plasma cells that make antibodies) and whether it can lower donor specific antibodies (DSA) levels to low enough levels to permit patients to proceed with allogeneic peripheral blood transplant (alloBMT). Those being asked to participate have high DSA levels that puts those being asked to participate at high risk of rejecting the available donor's blood stem cells and making those being asked to participate ineligible to receive a stem cell transplant.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Multiple Myeloma
Myelodysplastic Syndrome
Chronic Lymphocytic Leukemia
Hodgkin Lymphoma
Chronic Myeloid Leukemia
Myeloproliferative Neoplasm
Prior therapy
Cannot have received: anti-CD38 therapy (Daratumumab-SC)
Exception: unless a re-treatment study
Previous exposure to Daratumumab-SC or other anti-CD38 therapy (unless a re-treatment study)
Cannot have received: investigational drug or device
Exposure to an investigational drug (including investigational vaccine) or invasive investigational medical device for any indication within 4 weeks or 5 pharmacokinetic half-lives, whichever is longer.
Cannot have received: radiation therapy
Exception: palliative radiotherapy for symptomatic management but not on measurable extramedullary plasmacytoma
Focal radiation therapy within 14 days prior to beginning of planned RIC allogeneic peripheral blood stem cell transplant regimen with the exception of palliative radiotherapy for symptomatic management but not on measurable extramedullary plasmacytoma
Lab requirements
Blood counts
ANC ≥ 500/mm3 (growth factor support allowed); Platelets ≥ 10,000/mm3 (platelet transfusion allowed); Hemoglobin: no specific cut-off (PRBC transfusion allowed)
Kidney function
Serum creatinine ≤ 2.0 mg/dL
Liver function
Bilirubin ≤ 3.0 mg/dL (unless due to Gilbert's syndrome or hemolysis), ALT and AST < 5x ULN
Cardiac function
Left ventricular ejection fraction ≥ 35%
Participants must have adequate organ function for undergoing RIC allogeneic peripheral blood stem cell transplant, and for undergoing a clinical trial. Hematologic: ANC ≥ 500/mm3 (growth factor support allowed); Hemoglobin: no specific cut-off (PRBC transfusion allowed); Platelets ≥ 10,000/mm3 (platelet transfusion allowed). Liver: Bilirubin ≤ 3.0 mg/dL (unless due to Gilbert's syndrome or hemolysis), ALT and AST < 5x ULN. Renal: Serum creatinine ≤ 2.0 mg/dL. Cardiac: Left ventricular ejection fraction ≥ 35%. Pulmonary: FEV1 ≥ 50%.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Baltimore, Maryland
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