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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Diagnosis of systemic AL amyloidosis;

• Patients must have received standard-of-care daratumumab, bortezomib, they do not have at least one organ response, and have not get complete hematological response;

• Life expectancy greater than 12 weeks;

• HGB ≥70g/L;

• Blood oxygen saturation \> 90%;

• Total bilirubin (TBil) ≤3×upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0×ULN;

• Informed consent explained to, understood by and signed by the patient.

Locations
Other Locations
China
Fuxing Hospital affiliated to Capital Medical University
RECRUITING
Beijing
Peking University Peoples Hospital
RECRUITING
Beijing
Contact Information
Primary
Yang Dr, M.D.
pkuphliuyang@bjmu.edu.cn
+86-10-88326542
Time Frame
Start Date: 2025-03-29
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 20
Treatments
Other: Group 1
Teclistamab monotherapy
Related Therapeutic Areas
Sponsors
Leads: Peking University People's Hospital

This content was sourced from clinicaltrials.gov