Teclistamab in Newly Diagnosed Mayo Stage IIIB AL Amyloidosis

Launched by PEKING UNION MEDICAL COLLEGE HOSPITAL · Jul 22, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called teclistamab for people recently diagnosed with a condition called AL amyloidosis, specifically those at an advanced stage known as Mayo stage IIIB. AL amyloidosis happens when abnormal proteins build up in the body’s organs, causing damage. This study aims to find out if teclistamab is safe and effective for treating these patients.

To join the trial, participants need to have a confirmed diagnosis of AL amyloidosis at this specific stage and meet certain lab test levels. The study is open to adults aged 65 to 74, regardless of gender. People with certain other health problems, such as uncontrolled infections, other active cancers, serious heart conditions, or certain liver or kidney problems, would not be eligible. If you join, you can expect to receive teclistamab while doctors carefully monitor your health to see how well the treatment works and to watch for any side effects. This trial is currently recruiting patients, so if you or a loved one fits the criteria, you might consider discussing this option with your healthcare provider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Biopsy confirmed AL amyloidosis
• • Mayo 2004 stage IIIB
• • dFLC ≥ 50mg/L
• Exclusion Criteria:
• • Co-morbidity of uncontrolled infection
• • Co-morbidity of other active malignancy
• • Co-diagnosis of multiple myeloma or waldenstrom macroglobulinemia
• • Co-morbidity of grade 2 Mobitz II or grade 3 atrioventricular block (expect for those with implanted pacemaker)
• • Co-morbidity of sustained or recurrent nonsustained ventricular tachycardia
• • Seropositive for human immunodeficiency virus
• • Hepatitis B virus (HBV)-DNA \> 1000 copies/mL
• • Seropositive for hepatitis C (except in the setting of a sustained virologic response)
• • Neutrophil \<1×10E9/L, hemoglobin \< 8g/dL, or platelet \< 75×10E9/L.
• • Severely compromised hepatic or renal function: alanine transaminase (ALT) or aspertate aminotransferase (AST) \> 5 × upper limit of normal (ULN), total bilirubin \> 2 × ULN, estimated glomerular filtration rate \< 20 mL/min, or receiving renal replacement therapy