Teclistamab in Previously Treated AL Amyloidosis

Recruiting now · Phase 2

Conditions studied: AL Amyloidosis

In brief

This is a phase II study in patients with previously treated immunoglobulin light-chain (AL) Amyloidosis to evaluate the efficacy and safety of teclistamab

Key facts

Study ID: NCT06935162
Run by: Peking Union Medical College Hospital
People needed: 30
Starts: 2025-05-21
Expected to finish: 2028-12-31
Last updated by the study team: 2025-05-25

Who can join

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

You may qualify if…

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

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

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