Teclistamab in Newly Diagnosed Mayo Stage IIIB AL Amyloidosis

Not Applicable

Recruiting

• Conditions: AL Amyloidosis
• Interventions: Drug: Teclistamab (Tec)

• Registration Number: NCT07079423
• Lead Sponsor: Peking Union Medical College Hospital

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2025-06-28
• Status Verified: 2025-07
• Study First Submitted: 2025-07-11
• Study First Submitted QC: 2025-07-22
• Last Update Submitted: 2025-07-22
• Study First Posted: 2025-07-23
• Last Update Posted: 2025-07-23
• Primary Completion: 2027-01-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Teclistamab	Teclistamab (Tec)	Teclistamab will be administered via a subcutaneous injection

Primary Outcome Measures

Name	Time	Method
Stringent difference in involved and uninvolved free light chains (dFLC) response at 1 months after treatment initiation	at 1 months after treatment initiation	Stringent dFLC response is defined as dFLC \< 10 mg/L or involved free light chain (FLC) ≤ 20 mg/L, and FLC will be tested using FreeLite assay (Binding Site).

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, China