Teclistamab in Previously Treated AL Amyloidosis

Phase 2

Not yet recruiting

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

• Registration Number: NCT06935162
• Lead Sponsor: Peking Union Medical College Hospital

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-11
• Study First Submitted QC: 2025-04-11
• Last Update Submitted: 2025-04-11
• Study First Posted: 2025-04-20
• Last Update Posted: 2025-04-20
• Study Start: 2025-05-01
• Primary Completion: 2026-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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 Criteria

• 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

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
Hematologic complete response (CR) at 3 months after treatment initiation	at 3 months after treatment initiation