RecruitingPhase 2NCT06935162

Teclistamab in Previously Treated AL Amyloidosis

Teclistamab for Previously Treated Light-chain Amyloidosis Patients, a Phase II Study

Sponsor

Peking Union Medical College Hospital

Enrollment

30 participants

Start Date

May 21, 2025

Study Type

INTERVENTIONAL

Conditions

AL Amyloidosis

Summary

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

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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 Criteria11

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