NCT07079423RecruitingPhase 2
Teclistamab in Newly Diagnosed Mayo Stage IIIB AL Amyloidosis
Teclistamab for Newly Diagnosed Mayo Stage IIIB Light-chain Amyloidosis Patients, a Phase II Study
Source: ClinicalTrials.gov · Last updated 23 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This is a phase II study in patients with newly diagnosed Mayo stage IIIB immunoglobulin light-chain (AL) Amyloidosis to evaluate the efficacy and safety of teclistamab
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 35 (estimated)
- First submitted
- 11 Jul 2025
- Start date
- 28 Jun 2025
- Primary completion date
- 31 Jan 2027
- Lead sponsor
- Peking Union Medical College Hospital
- Diseases
- Amyloidosis
- NCT number
- NCT07079423
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 35
- From 28 Jun 2025 to the primary completion date, 31 Jan 2027
- 1 site 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
- Co-morbidity of uncontrolled infection
- Co-morbidity of other active malignancy
- Hepatitis B virus (HBV)-DNA \> 1000 copies/mL
- Seropositive for hepatitis C (except in the setting of a sustained virologic response)
Lab values
- Neutrophil \<1×10E9/L, hemoglobin \< 8g/dL, or platelet \< 75×10E9/L.
- Severely compromised hepatic or renal function: alanine transaminase (ALT) or aspertate aminotransferase (AST) \> 5 × upper limit of normal (ULN), total bilirubin \> 2 × ULN, estimated glomerular filtration rate \< 20 mL/min, or receiving renal replacement therapy
Other
- Co-diagnosis of multiple myeloma or waldenstrom macroglobulinemia
- Co-morbidity of grade 2 Mobitz II or grade 3 atrioventricular block (expect for those with implanted pacemaker)
- Co-morbidity of sustained or recurrent nonsustained ventricular tachycardia
- Seropositive for human immunodeficiency virus
Who the study is looking for
- Biopsy confirmed AL amyloidosis
- Mayo 2004 stage IIIB
- dFLC ≥ 50mg/L
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.