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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

37

Participants

Timeline

Start Date

February 15, 2024

Primary Completion Date

March 1, 2026

Study Completion Date

September 1, 2026

Conditions
AL AmyloidosisAmyloidosis
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 4 weeks, 6 weeks,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 4 weeks, 6 weeks, 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

Trial Locations (5)

55905

NOT_YET_RECRUITING

Mayo Clinic, Rochester

75390

RECRUITING

UT Southwestern Medical Center, Dallas

94305-5456

NOT_YET_RECRUITING

Stanford Cancer Institute, Stanford

02111

NOT_YET_RECRUITING

Tufts Medical Center, Inc., Boston

02215

NOT_YET_RECRUITING

Dana-Farber Cancer Institute, Boston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

University of Texas Southwestern Medical Center

OTHER

NCT05145816 - Phase 1/2a Study of Belantamab Mafodotin in Relapsed or Refractory AL Amyloidosis | Biotech Hunter | Biotech Hunter