WithdrawnPhase 1

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

Stopped: Sorrento Therapeutics filed for chapter 11 bankruptcy.

0Started 2023-09

Plain-language 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

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Hemoglobin \< 8.0 g/dL
✕. Platelet count \< 50,000/μL
✕. Absolute neutrophil count (ANC) \< 1000/ μL
✕. Serum creatinine \> 2.0 x the upper limit of normal (ULN), or estimated creatinine clearance \< 45 mL/min (using the Cockcroft-Gault equation).
✕. Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3x ULN or serum total bilirubin \> 1.5x ULN (except for patients in whom hyperbilirubinemia is attributed to Gilbert's Syndrome)

What they're measuring

Safety of STI-6129

Timeframe: Baseline through study completion at up to approximately 24 months

Trial details

NCT IDNCT05692908

SponsorSorrento Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-09

View on ClinicalTrials.gov More Light Chain (AL) Amyloidosis trials