Actively Recruiting
Phase 1/2a Study of Belantamab Mafodotin in Relapsed or Refractory AL Amyloidosis
Led by University of Texas Southwestern Medical Center · Updated on 2026-05-07
37
Participants Needed
3
Research Sites
184 weeks
Total Duration
On this page
Sponsors
U
University of Texas Southwestern Medical Center
Lead Sponsor
G
GlaxoSmithKline
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Phase 1/2a Study of Belantamab Mafodotin in Relapsed or Refractory AL Amyloidosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with relapsed or refractory AL amyloidosis with prior treatment including proteosome inhibitor, alkylator, anti-CD38 antibody, and/or autologous stem cell transplant
- Or have failed or are intolerant/ineligible for these treatments
- Age 18 years or older at consent
- Histological confirmation of systemic AL amyloidosis with appropriate tests
- Measurable disease markers within 28 days before registration
- At least one organ affected by AL amyloidosis as defined by cardiac, kidney, liver, gastrointestinal, lung, or soft tissue involvement
- Completed prior systemic therapy or investigational drug at least 28 days before registration
- Medical history and physical exam within 14 days before registration
- New York Heart Association (NYHA) Class 1 to 3a heart failure stable for 56 days
- ECOG performance status 0 to 2
- Left ventricular ejection fraction over 35% within 28 days before registration
- Adequate blood counts and organ function within 14 days before registration
- Females of childbearing potential must have negative pregnancy tests and agree to use effective contraception during and for 4 months after treatment
- Male participants must agree to abstain from sperm donation and use contraception during and for 6 months after treatment
- Patients with HIV or hepatitis B or C infection may be eligible under specific conditions
You will not qualify if you...
- Prior treatment for active symptomatic multiple myeloma
- Any corneal disease except mild epithelial punctate keratopathy
- Known allergy or hypersensitivity to Belantamab Mafodotin or related drugs
- Eligible for autologous stem cell transplantation
- Significant cardiovascular conditions such as very high NT-proBNP, advanced heart failure (NYHA 3b or 4), ischemic heart disease-related heart failure, recent unstable heart failure, serious arrhythmias without pacemaker, prolonged QTc interval over 500 msec, symptomatic autonomic neuropathy, recent acute coronary events, solid organ transplant, recent stroke or TIA, uncontrolled arrhythmias, or uncontrolled hypertension
- History of cancer within 2 years except for certain treated skin or cervical cancers
- Uncontrolled medical conditions that increase risk
- Inability or unwillingness to comply with study procedures
- Recent use of investigational drugs or devices within 4 weeks
- Use of contact lenses during study
- Major surgery within 4 weeks before treatment
- Active mucosal or internal bleeding
- Serious or unstable medical or psychiatric conditions interfering with safety or compliance
- Pregnancy or lactation
- Current enrollment in other interventional clinical trials
- Active infection requiring treatment
- Unstable liver or biliary disease except stable chronic conditions or malignancy involvement
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Not Yet Recruiting
2
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
3
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States, 84112
Not Yet Recruiting
Research Team
D
Donglan Xia
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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