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Monoclonal Antibodies
Darzalex Faspro for Blood Cancers
Phase < 1
Recruiting
Led By Christian B Gocke, MD, PhD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Must not have
Chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) < 50% of predicted normal.
Previous exposure to Daratumumab-SC or other anti-CD38 therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to study if a medication called Darzalex Faspro can reduce specific antibodies in the blood to allow patients to safely undergo a stem cell transplant. People with high levels of these antibodies
Who is the study for?
This trial is for adults with certain blood cancers or conditions like leukemia, lymphoma, and myelodysplastic syndrome who are at high risk of stem cell transplant rejection due to high donor specific antibodies. They must be over 18, willing to participate in a clinical trial, have adequate organ function for the transplant and no other suitable donors.
What is being tested?
The study tests Darzalex Faspro's ability to lower donor specific antibody levels enough for patients to undergo an allogeneic peripheral blood stem cell transplant safely. It aims to see if this treatment can prevent the rejection of transplanted cells in those at high risk.
What are the potential side effects?
Darzalex Faspro may cause side effects such as infusion reactions (like fever or chills), fatigue, nausea, bone pain, and allergic responses. It targets plasma cells so it might also affect normal immune functions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My organs are healthy enough for a stem cell transplant and a clinical trial.
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I don't have any other suitable donor options available.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My lung function is less than half of what is expected for someone my age and size.
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I have been treated with Daratumumab or another anti-CD38 therapy before.
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I have had severe or uncontrolled asthma in the last 2 years.
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I have been diagnosed with multiple myeloma or AL amyloidosis.
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I am scheduled for a bone marrow transplant or will use bone marrow/cord blood for stem cell therapy.
Select...
I have a history of HIV infection.
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I do not have serious heart conditions or recent heart attacks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Efficacy as assessed by percentage of patients with reduced DSA levels
Safety as assessed by proportion of patients with grade 3 or higher toxicities
Secondary study objectives
Number of participants who achieve T-cell chimerism
Number of participants who have primary graft failure
Time (days) to neutrophilic recovery
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Daratumumab-SC followed by standard of care DSA desensitization and alloBMTExperimental Treatment2 Interventions
Darzalex Faspro (Daratumumab and hyaluronidase-fihj) will be administered subcutaneously (SC) weekly (every 7 day +/- 1 day) for a total of four doses followed by standard desensitization regimen and allogeneic stem cell transplant.
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Who is running the clinical trial?
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
570 Previous Clinical Trials
33,222 Total Patients Enrolled
1 Trials studying Blood Cancers
130 Patients Enrolled for Blood Cancers
Janssen Research & Development, LLCIndustry Sponsor
1,007 Previous Clinical Trials
6,403,439 Total Patients Enrolled
Christian B Gocke, MD, PhDPrincipal InvestigatorJohns Hopkins University
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