Teclistamab in Newly Diagnosed Mayo Stage IIIB AL Amyloidosis

Recruiting now · Phase 2

Conditions studied: AL Amyloidosis

In brief

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

Key facts

Study ID

NCT07079423

Run by

Peking Union Medical College Hospital

People needed

35

Starts

2025-06-28

Expected to finish

2027-12-31

Last updated by the study team

2025-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Biopsy confirmed AL amyloidosis
• Mayo 2004 stage IIIB
• dFLC ≥ 50mg/L

You may not qualify if…

• 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

Where it is running

• Peking Union Medical College Hospital — Beijing, China (enrolling)

Full record on ClinicalTrials.gov

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