Prospective Study of Teclistamab in the Treatment of Systemic AL Amyloidosis
Recruiting now · Not applicable
Conditions studied: AL Amyloidosis
In brief
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.
Key facts
- Study ID
- NCT06699394
- Run by
- Peking University People's Hospital
- People needed
- 20
- Starts
- 2025-03-29
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2025-04-24
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma.
- 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;
- Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.
Where it is running
- Peking University Peoples Hospital — Beijing, Beijing Municipality, China (enrolling)
- Fuxing Hospital affiliated to Capital Medical University — Beijing, China (enrolling)
Full record on ClinicalTrials.gov
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