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New treatment option for Hematologic Malignancy
Official 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
ClinicalTrials.gov ID: NCT06398457
What this study is testing
What is Darzalex Faspro (Daratumumab and hyaluronidase-fihj)?
Darzalex Faspro (Daratumumab and hyaluronidase-fihj) is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for hematologic malignancy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participates must meet all other institutional criteria for the planned reduced intensity conditioning allogeneic peripheral blood stem cell...
- Participants must be ≥18 years of age.
- Participants must have adequate organ function for undergoing RIC allogeneic peripheral blood stem cell transplant, and for undergoing a clinical...
- people are eligible if there are high levels of Donor Specific Antibody levels based on protocol specific scoring system regardless of prior attempts...
- Participants must have a no other readily available suitable alternative donor.
You likely can't join if
- Previous exposure to Daratumumab-SC or other anti-CD38 therapy
- Exposure to Daratumumab-SC or other anti-CD38 therapies (unless a re-treatment study)
- Exposure to an investigational drug (including investigational vaccine) or invasive investigational medical device for any indication within 4 weeks...
- Focal radiation therapy within 14 days prior to beginning of planned RIC allogeneic peripheral blood stem cell transplant regimen with the exception...
- Chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) \< 50% of predicted normal. Note that FEV1 testing is...
- Moderate or severe persistent asthma within the past 2 years, or uncontrolled asthma of any classification. Note that participants who currently have...
See the full eligibility criteria
- Participates must meet all other institutional criteria for the planned reduced intensity conditioning allogeneic peripheral blood stem cell transplant (RIC alloHSCT) as defined in Johns Hopkins BMT Policy; all...
- Participants must be ≥18 years of age.
- Participants must have adequate organ function for undergoing RIC allogeneic peripheral blood stem cell transplant, and for undergoing a clinical trial. a. Hematologic. i. White blood cell (WBC). ANC ≥ 500/mm3 (growth...
- people are eligible if there are high levels of Donor Specific Antibody levels based on protocol specific scoring system regardless of prior attempts at standard desensitization.
- Participants must have a no other readily available suitable alternative donor.
- All potential Participants must be pre-approved by BMT faculty consensus.
- Participants must have adequate willingness to participate in a clinical trial.
- Previous exposure to Daratumumab-SC or other anti-CD38 therapy
- Exposure to Daratumumab-SC or other anti-CD38 therapies (unless a re-treatment study)
- 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.
- 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...
- Chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) \< 50% of predicted normal. Note that FEV1 testing is required for participants suspected of having COPD and participants...
- Moderate or severe persistent asthma within the past 2 years, or uncontrolled asthma of any classification. Note that participants who currently have controlled intermittent asthma or controlled mild persistent asthma...
- Known hypersensitivity or intolerance to boron or mannitol, sorbitol, corticosteroids, monoclonal antibodies or human proteins, or the excipients
- Diagnosis of multiple myeloma or Amyloid light-chain (AL) amyloidosis
- A planned myeloablative alloBMT or the planned use of bone marrow or cord blood as a stem cell source
- History of HIV infection at any time in past.
- Seropositive for hepatitis B (HBV) (defined by a positive test for hepatitis B surface antigen [HBsAg] positive, or antibodies to hepatitis B surface and/or core antigens [antiHBs or antiHBc, respectively] with...
- Seropositive for hepatitis C (except in the setting of a sustained virologic response (SVR), defined as aviremia at least 12 weeks after completion of antiviral therapy)
- Clinically significant cardiac disease, including:
- Myocardial infarction within 6 months before RIC alloHSCT or unstable or uncontrolled disease/condition related to or affection cardiac function (e.g., unstable angina, congestive heart failure, New York Heart...
- Uncontrolled cardiac arrhythmia
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.