Actively Recruiting
Teclistamab in Newly Diagnosed Mayo Stage IIIB AL Amyloidosis
Led by Peking Union Medical College Hospital · Updated on 2025-07-23
35
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Teclistamab in Newly Diagnosed Mayo Stage IIIB AL Amyloidosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Biopsy confirmed AL amyloidosis
- Mayo 2004 stage IIIB
- Difference in involved and uninvolved free light chains (dFLC) 50 mg/L
You will not qualify if you...
- Uncontrolled infection
- Other active malignancy
- Diagnosis of multiple myeloma or Waldenstrom macroglobulinemia
- Grade 2 Mobitz II or grade 3 atrioventricular block unless with implanted pacemaker
- Sustained or recurrent nonsustained ventricular tachycardia
- Positive for human immunodeficiency virus
- Hepatitis B virus (HBV)-DNA over 1000 copies/mL
- Positive for hepatitis C unless sustained virologic response
- Low blood counts: neutrophils <1 x 10^9/L, hemoglobin <8 g/dL, or platelets <75 x 10^9/L
- Severely compromised liver or kidney function: ALT or AST > 5 times upper normal limit, total bilirubin > 2 times upper normal limit, estimated glomerular filtration rate < 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, 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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