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NCT05145816 · ClinicalTrials.gov registry record · Phase 1
Phase 1/2a Study of Belantamab Mafodotin in Relapsed or Refractory AL Amyloidosis
A Phase 1 study of Amyloidosis and AL Amyloidosis, sponsored by University of Texas Southwestern Medical Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
- 3
- Study locations
NCT05145816: Recruiting Phase 1 study of Amyloidosis and AL Amyloidosis, sponsored by University of Texas Southwestern Medical Center.
NCT05145816 is a Phase 1 study of Amyloidosis and AL Amyloidosis that is actively recruiting participants, run by University of Texas Southwestern Medical Center. The registered enrollment target is 37 participants, below the 1,128-participant average among 28 other Amyloidosis trials with a reported enrollment target (97% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05145816, a Phase 1 study of Amyloidosis and AL Amyloidosis, is actively recruiting participants, sponsored by University of Texas Southwestern Medical Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
- 3
- Study locations
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
Primary Outcome
Safety/Tolerability is measured by the number of participants treated with different dose level of belantamab mafodotin who experience dose limiting toxicity adverse events (AE) \>= Grade 3, as defined by Common Terminology Criteria for Adverse Events by CTCAE v5.0 for Part 1.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2024-02-15 |
| Est. Completion | 2026-09-01 |
| Phase | Phase 1 |
What NCT05145816 shows while recruiting
NCT05145816 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 1,128-participant average among 28 other Amyloidosis trials with a reported enrollment target (97% lower).
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.
NCT05145816 reports a single indexed study location in Tennessee, Texas, Utah.
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.
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).
Who is sponsoring clinical trial NCT05145816?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Amyloidosis
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 NCT05145816's enrollment target sits among peer trials
37 20th of 28 higher than 8 of 28 other Amyloidosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Amyloidosis 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.
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