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

NCT05145816 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2026-05-07

No results posted yet for this 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

Conditions

  • AL Amyloidosis
  • Amyloidosis

Interventions

DRUG

Belantamab mafodotin 2.5 mg/kg (8 weeks)

2.5 mg/kg IV Belantamab mafodotin IV every 8 weeks for Part 1

DRUG

Belantamab mafodotin 1.9 mg/kg (8 weeks)

1.9 mg/kg IV Belantamab mafodotin IV every 8weeks for Part 1

DRUG

Belantamab mafodotin 1.4 mg/kg (12 weeks)

1.4 mg/kg Belantamab mafodotin IV every 12 weeks for Part 1

DRUG

Belantamab mafodotin 1.9 mg/kg (12 weeks)

1.9 mg/kg Belantamab mafodotin IV every 12 weeks for Part 1

DRUG

Belantamab mafodotin every 8 weeks or 12 weeks as determined by Part 1 recommended dosages

Belantamab mafodotin Dose 1.0 mg/kg, 1.4 mg/kg, 1.9mg/kg or 2.5mg/kg every 8 weeks or 12 weeks as determined by Part 1 recommended dosages.

DRUG

Belantamab mafodotin 1.0 mg/kg (12 weeks)

1.0 mg/kg Belantamab mafodotin IV every 12 weeks for Part 1

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Larry Anderson, MD · University of Texas Southwestern Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-15
Primary Completion
2027-03-01
Completion
2027-09-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05145816 on ClinicalTrials.gov