Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
NCT06398457

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

Led by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Updated on 2025-09-26

8

Participants Needed

1

Research Sites

127 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

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.

CONDITIONS

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must meet all other institutional criteria for planned reduced intensity conditioning allogeneic peripheral blood stem cell transplant (RIC alloHSCT) including all donor types
  • Participants must be 18 years of age or older
  • Participants must have adequate organ function: white blood cell count with ANC 65 500/mm3, hemoglobin (no specific cut-off), platelets 65 10,000/mm3; liver bilirubin 64 3.0 mg/dL (unless due to Gilbert's syndrome or hemolysis), ALT and AST less than 5 times upper limit normal
  • Serum creatinine 64 2.0 mg/dL
  • Left ventricular ejection fraction 65 35%
  • Pulmonary function with FEV1 65 50%
  • Participants must have high levels of donor specific antibodies based on protocol scoring regardless of prior desensitization attempts
  • Participants must have no readily available suitable alternative donor
  • All participants must be pre-approved by bone marrow transplant faculty consensus
  • Participants must have adequate willingness to participate in the clinical trial
Not Eligible

You will not qualify if you...

  • Previous exposure to Daratumumab-SC or other anti-CD38 therapy
  • Exposure to investigational drug or invasive medical device within 4 weeks or 5 half-lives
  • Focal radiation therapy within 14 days before planned transplant regimen, except palliative radiotherapy
  • Chronic obstructive pulmonary disease with FEV1 less than 50% predicted
  • Moderate or severe persistent asthma within past 2 years or uncontrolled asthma
  • Known allergy or intolerance 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 stem cell source
  • History of HIV infection
  • Seropositive for hepatitis B with positive HBV DNA PCR
  • Seropositive for hepatitis C without sustained virologic response
  • Significant cardiac disease including recent myocardial infarction, unstable angina, congestive heart failure NYHA Class III-IV, or uncontrolled arrhythmia

AI-Screening

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Trial Site Locations

Total: 1 location

1

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States, 21231

Actively Recruiting

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Research Team

C

Christian B Gocke, MD PhD

CONTACT

A

Amanda Stevens, MD

CONTACT

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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