NCT06699394

Prospective Study of Teclistamab in the Treatment of Systemic AL Amyloidosis

Teclistamab in Systemic AL Amyloidosis: a Multi-center Prospective Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the use of teclistamab in systemic AL amyloidosis and answer whether teclistamab can improve the rate of complete hematological response. This is a single-arm, multi-center, prospective study. Participants will receive the single drug teclistamab, which the investigator deems the best choice.

Detailed description

The treatment of amyloidosis should focus more on complete hematological response (CHR) and organ response rate. We hypothesize that teclistamab can deeply eliminate cloned plasma cells in AL patients, achieving a high proportion of complete hematological response. In clinical practice, if daratumumab, bortezomib, and venetoclax (for patients with t(11;14)）have been used, the outcome is poor. Also, CHR is correlated with better clinical outcomes. In clinical routine practice, we use teclistamab, a more effective treatment to eliminate clonal plasma cells. To further explore efficacy and safety, we designed this prospective study.

Conditions

• AL Amyloidosis

Interventions

Type	Name	Description
DRUG	Teclistamab (Tec)	Teclistamab is administered subcutaneously with higher step-up doses (SUDs). Patients receive teclistamab with SUDs: 0.2 and 0.7 mg/kg and 1.5 mg/kg in Cycle 1 (2-4 days between doses). 3 mg/kg every 4 weeks will be used in subsequent cycles.

Timeline

• Start date: 2025-03-29
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2024-11-21
• Last updated: 2025-04-24

Locations

2 sites across 1 country: China