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)

Peking Union Medical College Hospital

Beijing, China

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NCT07079423


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