Actively Recruiting
Teclistamab in Previously Treated AL Amyloidosis
Led by Peking Union Medical College Hospital · Updated on 2025-05-25
30
Participants Needed
1
Research Sites
188 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase II study in patients with previously treated immunoglobulin light-chain (AL) Amyloidosis to evaluate the efficacy and safety of teclistamab
CONDITIONS
Official Title
Teclistamab in Previously Treated AL Amyloidosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Biopsy confirmed AL amyloidosis
- Patients must have received at least one line of treatment, including daratumumab and bortezomib
- Relapse from previous treatment, or less than partial response after two cycles of treatment/less than very good partial response after three cycles of treatment
- dFLC > 50mg/L
You will not qualify if you...
- Previous anti-BCMA targeted therapy
- Co-morbidity of uncontrolled infection
- Co-morbidity of other active malignancy
- Co-diagnosis of multiple myeloma or waldenstrom macroglobulinemia
- Co-morbidity of grade 2 Mobitz II or grade 3 atrioventricular block (except for those with implanted pacemaker)
- Co-morbidity of sustained or recurrent nonsustained ventricular tachycardia
- Seropositive for human immunodeficiency virus
- Hepatitis B virus (HBV)-DNA > 1000 copies/mL
- Seropositive for hepatitis C (except in the setting of a sustained virologic response)
- Neutrophil <1×10E9/L, hemoglobin < 8g/dL, or platelet < 75×10E9/L
- Severely compromised hepatic or renal function: alanine transaminase (ALT) or aspartate aminotransferase (AST) > 5 × upper limit of normal (ULN), total bilirubin > 2 × ULN, eGFR < 20 mL/min, or receiving renal replacement therapy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
K
Kaini Shen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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