NCT06398457View on ClinicalTrials.gov

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

EARLY_PHASE1RecruitingINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

September 19, 2024

Primary Completion Date

September 30, 2026

Study Completion Date

March 31, 2027

Conditions
Hematologic MalignancyBone Marrow Transplant RejectionAcute Myeloid Leukemia (AML)Myelodysplastic Syndromes (MDS)Acute Lymphoblastic Leukemia (ALL), AdultMultiple MyelomaAplastic AnemiaLymphomaNon Hodgkin LymphomaHodgkin LymphomaChronic Myeloid LeukemiaMyelofibrosis
Interventions
DRUG

Darzalex Faspro (Daratumumab and hyaluronidase-fihj)

Darzalex Faspro will be administered weekly as a subcutaneous injection on Days -42, -35, -28 and -21 (+/- 1 day) for a total of four doses at 1800 mg each.

DEVICE

JH-DSA Semi-Quant Screen and Response Score

Serum based semi-quantifiable investigational testing regimen used to screen for high DSA level or assess response to desensitization. It is based on results from cross-matched flow cytometric assessment cellular-based and solid phase immunoassays (SPI) that estimates antibody level.

Trial Locations (1)

21231

RECRUITING

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore

All Listed Sponsors
collaborator

Janssen Research & Development, LLC

INDUSTRY

lead

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER