Teclistamab in Newly Diagnosed Mayo Stage IIIB AL Amyloidosis

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Enrolling; Phase 2

Conditions: AL Amyloidosis

Treatments: Drug: Teclistamab (Tec)

Study type: Interventional

Funder types: Other

Identifiers

NCT07079423

TEC-IIIB AL

Details and patient eligibility

About

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

Enrollment: 35 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Teclistamab

Experimental group

Description:

Teclistamab will be administered via a subcutaneous injection

Treatment:

Drug: Teclistamab (Tec)