Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 12:52 AM
Study NCT ID:
NCT06699394
Status:
RECRUITING
Last Update Posted:
2025-04-24
First Post:
2024-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Study of Teclistamab in the Treatment of Systemic AL Amyloidosis
Sponsor:
Peking University People's Hospital
Organization:
Study Overview
Official Title:
Teclistamab in Systemic AL Amyloidosis: a Multi-center Prospective Study
Status:
RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: