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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 below

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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:

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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.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

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 more

Awards & 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.

0 / 10Eligibility criteria met