RecruitingPhase 2NCT07079423
Teclistamab in Newly Diagnosed Mayo Stage IIIB AL Amyloidosis
Teclistamab for Newly Diagnosed Mayo Stage IIIB Light-chain Amyloidosis Patients, a Phase II Study
Sponsor
Peking Union Medical College Hospital
Enrollment
35 participants
Start Date
Jun 28, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
This is a phase II study in patients with newly diagnosed Mayo stage IIIB immunoglobulin light-chain (AL) Amyloidosis to evaluate the efficacy and safety of teclistamab
Eligibility
Min Age: 18 Years
Inclusion Criteria3
- Biopsy confirmed AL amyloidosis
- Mayo 2004 stage IIIB
- dFLC ≥ 50mg/L
Exclusion Criteria10
- 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
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Interventions
DRUGTeclistamab (Tec)
Teclistamab will be administered via a subcutaneous injection
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07079423
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