Teclistamab in Previously Treated AL Amyloidosis

Launched by PEKING UNION MEDICAL COLLEGE HOSPITAL · Apr 11, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called teclistamab for patients with AL Amyloidosis who have already received other therapies. AL Amyloidosis is a condition where abnormal proteins build up in the body, affecting organs and tissues. The trial aims to find out if teclistamab is effective and safe for those who have not had a good response to previous treatments, specifically if their disease has relapsed or if they didn’t improve enough after their last treatments.

To be eligible for this trial, participants need to be between the ages of 65 and 74 and must have a confirmed diagnosis of AL Amyloidosis. They should have already received at least one treatment, including specific medications like daratumumab and bortezomib, but their condition must not have improved sufficiently after these treatments. Participants will be monitored closely for their health and safety during the trial, and there are certain health conditions that may prevent someone from joining, such as active infections or other serious health issues. This study is not yet recruiting, so it’s a good idea to talk with your healthcare provider for more information and updates.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Biopsy confirmed AL amyloidosis
• • Patients must have received at least one line of treatment, including daratumumab and bortezomib
• • Relapse from previous treatment, or less than partial response after two cycles of treatment/less than very good partial response after three cycles of treatment
• • dFLC \> 50mg/L
• Exclusion Criteria:
• • Previous anti-BCMA targeted therapy
• • 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, eGFR \< 20 mL/min, or receiving renal replacement therapy