Prospective Study of Teclistamab in the Treatment of Systemic AL Amyloidosis
Key facts
- Where
- Beijing, ChinaSee the 2 sites
Where in China
- Fuxing Hospital affiliated to Capital Medical UniversityBeijing, ChinaTaking people
- Peking University Peoples HospitalBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Peking University People's Hospital
- Trial code
- NCT06699394
- Record updated
- 24 April 2025
- Original description
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.Read full original descriptionShow less
Teclistamab in Systemic AL Amyloidosis: a Multi-center Prospective Study
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.
Inclusion: 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.
Exclusion: Presence of other tumors which is/are in advanced malignant stage and has/have systemic metastasis; Severe or persistent infection that cannot be effectively controlled; Presence of severe autoimmune diseases or immunodeficiency disease; Patients with active hepatitis B or hepatitis C ([HBVDNA+] or [HCVRNA+]); Patients with HIV infection or syphilis infection; Fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma; Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.