Tests teclistamab in people with AL amyloidosis who had prior treatment
Tests teclistamab in adults with previously treated AL amyloidosis, a rare protein disease.
Plain-language title generated from the registry record
Registry title: Teclistamab in Previously Treated AL Amyloidosis
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 2
Where in China
- Peking Union Medical College HospitalBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Peking Union Medical College Hospital
- Trial code
- NCT06935162
- Record updated
- 25 May 2025
- Original description
This is a phase II study in patients with previously treated immunoglobulin light-chain (AL) Amyloidosis to evaluate the efficacy and safety of teclistamabRead full original descriptionShow less
Teclistamab for Previously Treated Light-chain Amyloidosis Patients, a Phase II Study
This is a phase II study in patients with previously treated immunoglobulin light-chain (AL) Amyloidosis to evaluate the efficacy and safety of teclistamab
Inclusion: 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: Previous anti-BCMA targeted therapy; Co-morbidity of uncontrolled infection; Co-morbidity of other active malignancy; 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; 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.