NCT06699394Recruiting
Prospective Study of Teclistamab in the Treatment of Systemic AL Amyloidosis
Teclistamab in Systemic AL Amyloidosis: a Multi-center Prospective Study
Source: ClinicalTrials.gov · Last updated 24 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 18 Nov 2024
- Start date
- 29 Mar 2025
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Peking University People's Hospital
- Diseases
- Amyloidosis
- NCT number
- NCT06699394
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 29 Mar 2025 to the primary completion date, 31 Dec 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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;
Other
- 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.
Who the study is looking for
- 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.
Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University Peoples Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Fuxing Hospital affiliated to Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.