Actively Recruiting
Darzalex Faspro Before Standard Desensitization and Allogeneic Peripheral Blood Stem Cell Transplantation in Adults at High Risk for Primary Graft Failure Due to Donor Specific Antibodies
Led by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Updated on 2025-09-26
8
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
Sponsors
S
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead Sponsor
J
Janssen Research & Development, LLC
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must meet all institutional criteria for reduced intensity conditioning allogeneic peripheral blood stem cell transplant.
- Participants must be 18 years of age or older.
- Participants must have adequate organ function, including white blood cell count with ANC ≥ 500/mm3, hemoglobin (no specific cutoff), platelets ≥ 10,000/mm3, bilirubin ≤ 3.0 mg/dL (unless due to Gilbert's syndrome or hemolysis), ALT and AST less than 5 times the upper limit of normal, serum creatinine ≤ 2.0 mg/dL, left ventricular ejection fraction ≥ 35%, and FEV1 ≥ 50%.
- Participants must have high levels of donor specific antibodies based on protocol scoring.
- Participants must have no readily available suitable alternative donor.
- Participants must be pre-approved by bone marrow transplant faculty consensus.
- Participants must be willing to participate in a clinical trial.
You will not qualify if you...
- Previous exposure to Darzalex Faspro or other anti-CD38 therapy.
- Exposure to an investigational drug or invasive investigational device within 4 weeks or 5 pharmacokinetic half-lives.
- Focal radiation therapy within 14 days prior to planned transplant except palliative radiotherapy for symptom management.
- Chronic obstructive pulmonary disease with FEV1 less than 50% of predicted normal.
- Moderate or severe persistent asthma within past 2 years or uncontrolled asthma.
- Known hypersensitivity to boron, mannitol, sorbitol, corticosteroids, monoclonal antibodies, human proteins, or excipients.
- Diagnosis of multiple myeloma or amyloid light-chain amyloidosis.
- Planned myeloablative transplant or use of bone marrow or cord blood as stem cell source.
- History of HIV infection.
- Seropositive for hepatitis B or hepatitis C without sustained virologic response.
- Clinically significant cardiac disease including recent myocardial infarction, unstable angina, congestive heart failure, or uncontrolled arrhythmia.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive Darzalex Faspro as weekly subcutaneous injections for four doses, followed by standard desensitization with therapeutic plasma exchange, intravenous immunoglobulin, and immunosuppression prior to allogeneic peripheral blood stem cell transplantation.
4 weekly visits (in-person) for Darzalex Faspro administration
Trial Site Locations
Total: 1 location
1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231
Actively Recruiting
Research Team
C
Christian B Gocke, MD PhD
A
Amanda Stevens, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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