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NCT06398457 · ClinicalTrials.gov registry record · Early Phase 1

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

A Early Phase 1 study of Multiple Myeloma and Lymphoma, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

Recruiting
Registry status
Early Phase 1
Development phase
8
Enrollment target
1
Study location

NCT06398457: Recruiting Early Phase 1 study of Multiple Myeloma and Lymphoma, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

NCT06398457 is a Early Phase 1 study of Multiple Myeloma and Lymphoma that is actively recruiting participants, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 8 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06398457, a Early Phase 1 study of Multiple Myeloma and Lymphoma, is actively recruiting participants, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

RECRUITING
Registry status
Early Phase 1
Development phase
8 participants
Enrollment target
1
Study location

Study Summary

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.

Primary Outcome

Efficacy as assessed by the percentage of patients with DSA levels that are reduced to a level permissible for RIC alloHSCT with DSA strength of II or less and at least a 10% decrease in MFI from the baseline as determined by the JH-DSA Response Score.

Conditions Studied

Multiple Myeloma Lymphoma Non-Hodgkin Lymphoma Hodgkin Lymphoma Hematologic Malignancy Acute Myeloid Leukemia (AML) Aplastic Anemia Myelodysplastic Syndromes (MDS) Bone Marrow Transplant Rejection Acute Lymphoblastic Leukemia (ALL), Adult

Interventions

  • DRUG Darzalex Faspro (Daratumumab and hyaluronidase-fihj)
  • DEVICE JH-DSA Semi-Quant Screen and Response Score

Study Locations (1)

Maryland

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins - Baltimore

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2024-09-19
Est. Completion 2027-03
Phase Early Phase 1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

523 total trials

What NCT06398457 shows while recruiting

NCT06398457 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (99% lower).

The record links to 10 conditions, with Multiple Myeloma appearing as the primary indexed condition, and to 2 interventions - of which Darzalex Faspro (Daratumumab and hyaluronidase-fihj) is the first listed.

NCT06398457 reports a single indexed study location in Maryland.

Frequently Asked Questions

What is clinical trial NCT06398457 about?

NCT06398457 is a clinical study titled "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". 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 patien...

What is the current status of trial NCT06398457?

This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 8 participants. The study started on 2024-09-19. Estimated completion is 2027-03.

What conditions does trial NCT06398457 study?

This clinical trial studies the following conditions: Multiple Myeloma, Lymphoma, Non-Hodgkin Lymphoma, Hodgkin Lymphoma, Hematologic Malignancy.

What interventions are being tested in trial NCT06398457?

The interventions under investigation include: Darzalex Faspro (Daratumumab and hyaluronidase-fihj) (DRUG), JH-DSA Semi-Quant Screen and Response Score (DEVICE).

Who is sponsoring clinical trial NCT06398457?

This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06398457 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Multiple Myeloma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06398457's enrollment target sits among peer trials

8 428th of 438 higher than 10 of 438 other Multiple Myeloma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Multiple Myeloma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06398457

Source: ClinicalTrials.gov NCT06398457, the US trial registry maintained by the National Library of Medicine. NCT06398457 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.