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
Interested in this trial?
Get notified about updates and connect with the research team.
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
Related Trials
A Phase II Trial of Teclistamab in Participants With Previously Treated Immunoglobulin Light-chain (AL) Amyloidosis
NCT0664969510 locations
Promoting Diagnosis and Management of AL in Italy (ProDigALIty)
NCT063831434 locations
A Registry of AL Amyloidosis (ReAL)
NCT048390031 location
A EUropean REgistry and Sample Sharing networK to Promote the Diagnosis and Management of Light Chain Amyloidosis (EUREKA)
NCT062059536 locations
Daratumumab Maintenance Therapy for Improving Survival in Patients With Light Chain Amyloidosis, EMILIA Trial
NCT058986462 locations