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

Conditions

• AL Amyloidosis
• Amyloidosis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Belantamab mafodotin 2.5 mg/kg (8 weeks) — DRUG
  2.5 mg/kg IV Belantamab mafodotin IV every 8 weeks for Part 1
• Belantamab mafodotin 1.9 mg/kg (8 weeks) — DRUG
  1.9 mg/kg IV Belantamab mafodotin IV every 8weeks for Part 1
• Belantamab mafodotin 1.4 mg/kg (12 weeks) — DRUG
  1.4 mg/kg Belantamab mafodotin IV every 12 weeks for Part 1
• Belantamab mafodotin 1.9 mg/kg (12 weeks) — DRUG
  1.9 mg/kg Belantamab mafodotin IV every 12 weeks for Part 1
• Belantamab mafodotin every 8 weeks or 12 weeks as determined by Part 1 recommended dosages — DRUG
  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.
• Belantamab mafodotin 1.0 mg/kg (12 weeks) — DRUG
  1.0 mg/kg Belantamab mafodotin IV every 12 weeks for Part 1

Study Details

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

Key Dates

Start date

Feb 15, 2024

Status verified

May 2026

Primary completion

Mar 1, 2027

Completion

Sep 1, 2027

Study Design

Enrollment

37 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort (DL 0) for Part 1
  Cohort (DL 0) for Starting Dose : 1.9 mg/kg Belantamab mafodotin intravenously every 8 weeks
• Experimental: Cohort (DL +1) for Part 1
  Cohort (DL +1) for Dose Escalation: 2.5 mg/kg Belantamab mafodotin intravenously every 8 weeks
• Experimental: Cohort (DL -1) for Part 1
  Cohort (DL -1) for Dose De-escalation : 1.9 mg/kg Belantamab mafodotin intravenously every 12 weeks
• Experimental: Cohort (DL -2) for Part 1
  Cohort (DL -2) for Dose De-escalation: 1.4 mg/kg Belantamab mafodotin intravenously every 12 weeks
• Experimental: Cohort Dose Expansion for Part 2
  Cohort Dose expansion for Part 2: Belantamab mafodotin Dose from1.0 mg/kg to 2.5mg/kg every 8 or 12 weeks as determined by Part 1 recommended dosage calculations.
• Experimental: Cohort (DL -3) for Part 1
  Cohort (DL -3) for Dose De-escalation: 1.0 mg/kg Belantamab mafodotin intravenously every 12 weeks

Primary Outcome Measure

Safety/Tolerability as measured by number of subjects with dose limiting toxicity (Part 1) [ Time Frame: Up to 24 weeks from Cycle 1 Day 1 ]

Central Contacts

• Donglan Xia
  214-648-7097
  [email protected]

Locations (3)

Find similar trials in Nashville, TN

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