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RECRUITING Phase 1

Phase 1/2a Study of Belantamab Mafodotin in Relapsed or Refractory AL Amyloidosis

NCT05145816 · View on ClinicalTrials.gov ↗

Study Summary

The goal of this study is to test the safety of drug, Belantamab Mafodotin, and see what effects (good and bad) it has on people who take it and have amyloidosis, and to determine the most effective dose of the drug. The study will have 2 phases (parts). The first phase of the study will test different doses of Belantamab Mafodotin. The second phase will test Belantamab Mafodotin at the dose level found to be safe and effective in phase 1

Interventions

  • DRUG Belantamab mafodotin 2.5 mg/kg (8 weeks)
  • DRUG Belantamab mafodotin 1.9 mg/kg (8 weeks)
  • DRUG Belantamab mafodotin 1.4 mg/kg (12 weeks)
  • DRUG Belantamab mafodotin 1.9 mg/kg (12 weeks)
  • DRUG Belantamab mafodotin every 8 weeks or 12 weeks as determined by Part 1 recommended dosages

Study Locations (3)

Tennessee

  • Vanderbilt Ingram Cancer Center — Nashville

Texas

  • UT Southwestern Medical Center — Dallas

Utah

  • Huntsman Cancer Institute, University of Utah — Salt Lake City

Trial Details

FieldValue
Enrollment Target 37 participants
Start Date 2024-02-15
Est. Completion 2026-09-01
Phase Phase 1

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05145816

The ClinicalTrials.gov registry entry for NCT05145816 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas Southwestern Medical Center, which has 742 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Amyloidosis appearing as the primary indexed condition, and to 5 interventions — of which Belantamab mafodotin 2.5 mg/kg (8 weeks) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05145816 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Tennessee, Texas, Utah. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05145816 about?

NCT05145816 is a clinical study titled "Phase 1/2a Study of Belantamab Mafodotin in Relapsed or Refractory AL Amyloidosis". The goal of this study is to test the safety of drug, Belantamab Mafodotin, and see what effects (good and bad) it has on people who take it and have amyloidosis, and to determine the most effective dose of the drug. The study will have 2 phases (parts). The first phase of the study will test diffe...

What is the current status of trial NCT05145816?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2024-02-15. Estimated completion is 2026-09-01.

What conditions does trial NCT05145816 study?

This clinical trial studies the following conditions: Amyloidosis, AL Amyloidosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05145816?

The interventions under investigation include: Belantamab mafodotin 2.5 mg/kg (8 weeks) (DRUG), Belantamab mafodotin 1.9 mg/kg (8 weeks) (DRUG), Belantamab mafodotin 1.4 mg/kg (12 weeks) (DRUG), Belantamab mafodotin 1.9 mg/kg (12 weeks) (DRUG), Belantamab mafodotin every 8 weeks or 12 weeks as determined by Part 1 recommended dosages (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05145816?

This trial is sponsored by University of Texas Southwestern Medical Center, which has 742 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05145816 being conducted?

This trial has 3 study locations across Tennessee, Texas, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial