An Open-Label Study of the Safety of an Anti-CD38 Antibody Drug Conjugate (STI-6129) in Patients With AL Amyloidosis

Light Chain (AL) Amyloidosis Clinical Trial

Official title: An Open-Label, Dose-Escalation Study of the Safety of an Anti-CD38 Antibody Drug Conjugate (STI-6129) in Patients With Relapsed or Refractory Systemic AL Amyloidosis

Status Withdrawn

Clinical Trial Summary

This is a Phase 1 open-label, dose escalation trial designed to identify the recommended phase 2 dose of STI-6129 by assessing the safety, preliminary efficacy, and immunogenicity in subjects with relapsed or refractory systemic AL Amyloidosis

Clinical Trial Description

This study is an open-label, dose-finding, to identify the recommended phase 2 dose (RP2D) of STI-6129 by assessing the safety, and pharmacokinetics for the treatment of RRAL which is defined as the development of disease progression during therapy with an anti-AL amyloidosis treatment regimen or within 60 days of the last dose of an anti-AL amyloidosis treatment regimen or the achievement of less than a PR after ≥ 2 cycles.

The trial is the dose-escalation study. A standard dose escalation 3+3 will be utilized to identify dose-limiting toxiticy (DLTs) and a safe maximum tolerated dose (MTD) of STI-6129 in patients with R/R systemic AL amyloidosis. A total of 6 dosing cohorts are planned from 0.88 mg/kg to 3.68 mg/kg. Approximate dosing increments between cohorts are 1.33x up to the maximum planned dose level. ;

Related Conditions & MeSH terms

• Amyloidosis
• Immunoglobulin Light-chain Amyloidosis
• Light Chain (AL) Amyloidosis

• NCT number: NCT05692908
• Study type: Interventional
• Source: Sorrento Therapeutics, Inc.
• Status: Withdrawn
• Phase: Phase 1
• Start date: September 2023
• Completion date: November 2024