Phase 1/2a Study of Belantamab Mafodotin in Relapsed or Refractory AL Amyloidosis
Public ClinicalTrials.gov record NCT05145816. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Dose-Finding and Proof-of-Concept Phase 1/2a Study of Belantamab Mafodotin in Relapsed or Refractory AL Amyloidosis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT05145816
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 37 participants
Conditions and interventions
Conditions
Interventions
- 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
- Belantamab mafodotin 1.0 mg/kg (12 weeks) Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 14, 2024
- Primary completion
- Feb 28, 2027
- Completion
- Aug 31, 2027
- Last update posted
- Aug 18, 2026
2024 – 2027
United States locations
- U.S. sites
- 3
- U.S. states
- 3
- U.S. cities
- 3
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Vanderbilt Ingram Cancer Center | Nashville | Tennessee | 37232 | Recruiting |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | Recruiting |
| Huntsman Cancer Institute, University of Utah | Salt Lake City | Utah | 84112 | Not yet recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05145816, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 18, 2026 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05145816 live on ClinicalTrials.gov.