Darzalex Faspro (Daratumumab and Hyaluronidase-fihj) Before Standard Desensitization and Allogeneic Bone Marrow or Peripheral Blood Stem Cell Transplantation in Adult Patients at High-risk for Primary Graft Failure Secondary to Donor Specific Antibodies
A Pilot Study of Darzalex Faspro (Daratumumab and Hyaluronidase-fihj) Before Standard Desensitization and Allogeneic Bone Marrow or Peripheral Blood Stem Cell Transplantation in Adult Patients at High-risk for Primary Graft Failure Secondary to Donor Specific Antibodies
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether Darzalex Faspro is safe and can lower antibodies that attack a donor’s blood stem cells. It is for adults whose high antibody levels put them at risk of rejecting a stem cell transplant. The drug is given before the usual treatment to lower these antibodies.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older.
- Meet the center’s rules for a donor blood stem cell transplant using a less intense treatment plan.
- Have blood counts and liver, kidney, heart, and lung function that meet the study’s limits. Some blood transfusions and medicines to boost blood counts are allowed.
- Have high levels of antibodies against the donor, based on the study’s scoring system. Past treatment to lower these antibodies does not rule you out.
- Have no other suitable donor who is readily available.
- Have approval from the transplant doctors.
- Be willing to take part in a clinical trial.
Who can't join
- Past treatment with injected daratumumab or another drug targeting CD38, a protein on cells, unless this is a re-treatment study.
- Recent use of an experimental drug, vaccine, or invasive device: within 4 weeks, or longer for drugs that stay in the body longer. Radiation to one area within 14 days before transplant treatment also may rule you out, with limited exceptions for symptom relief.
- COPD, a long-term lung disease, with breathing test results below 50% of normal; moderate or severe ongoing asthma in the past 2 years; or uncontrolled asthma.
- Known allergy or intolerance to boron, mannitol, sorbitol, steroid medicines, antibody medicines, human proteins, or other treatment ingredients.
- Multiple myeloma, a blood cancer, or AL amyloidosis, a disease that causes protein buildup in organs.
- A planned transplant using a high-intensity treatment plan, bone marrow, or cord blood instead of blood stem cells.
- Any history of HIV; hepatitis B tests showing infection under the study’s rules; or a positive hepatitis C test unless the virus has stayed undetectable for at least 12 weeks after treatment.
- Serious heart disease, including a heart attack within 6 months before transplant treatment, unstable or uncontrolled heart problems, or an uncontrolled abnormal heartbeat.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. 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 potential non-cord blood donor sources are included: matched related, haploidentical, matched unrelated, mismatched unrelated. 2. Participants must be ≥18 years of age. 3. 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 factor support allowed). ii. Hemoglobin. No specific cut-off. (PRBC transfusion allowed). iii. Platelets. Platelets ≥ 10,000/mm3 (platelet transfusion allowed). b. Liver. Bilirubin ≤ 3.0 mg/dL (unless due to Gilbert's syndrome or hemolysis), and Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) \< 5x Upper limit of normal (ULN) c. Renal. Serum creatinine ≤ 2.0 mg/dL. d. Cardiac. Left ventricular ejection fraction ≥ 35%. e. Pulmonary. FEV1 ≥ 50%. 4. Subjects 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. 5. Participants must have a no other readily available suitable alternative donor. 6. All potential Participants must be pre-approved by BMT faculty consensus. 7. Participants must have adequate willingness to participate in a clinical trial. Exclusion Criteria: 1. Previous exposure to Daratumumab-SC or other anti-CD38 therapy 1. Exposure to Daratumumab-SC or other anti-CD38 therapies (unless a re-treatment study) 2. 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. 3. 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 2. 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 must be excluded if FEV1 is \< 50% of predicted normal. 3. 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 are allowed to participate. 4. Known hypersensitivity or intolerance to boron or mannitol, sorbitol, corticosteroids, monoclonal antibodies or human proteins, or the excipients 5. Diagnosis of multiple myeloma or Amyloid light-chain (AL) amyloidosis 6. A planned myeloablative alloBMT or the planned use of bone marrow or cord blood as a stem cell source 7. History of HIV infection at any time in past. 8. 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 hepatitis B virus \[HBV\]- DNA quantitation positive). Patients who are positive for antiHBs and/or antiHBc must have a negative polymerase chain reaction (PCR) for HBV-DNA quantitation result during screening. Patients with serologic findings suggestive of HBV vaccination (antiHBs positivity as the only serologic marker) AND a known history of prior HBV vaccination do not need to be tested for HBV DNA by PCR. Those who are PCR positive will be excluded. 9. 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) 10. Clinically significant cardiac disease, including: 1. 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 Association Class III-IV) 2. Uncontrolled cardiac arrhythmia
Study sites (1)
MD
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Baltimore, MD 21231Christian Gocke, MD · Study contact · 443-287-7104 · cgocke2@jhmi.eduPhirun Mindel, RN · Study contact · 4432870388 · pvang1@jhmi.eduMore trials in Baltimore