Status:
RECRUITING
Teclistamab in Previously Treated AL Amyloidosis
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
AL Amyloidosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a phase II study in patients with previously treated immunoglobulin light-chain (AL) Amyloidosis to evaluate the efficacy and safety of teclistamab
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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 (expect 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 aspertate aminotransferase (AST) \> 5 × upper limit of normal (ULN), total bilirubin \> 2 × ULN, eGFR \< 20 mL/min, or receiving renal replacement therapy
Key Trial Info
Start Date :
May 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06935162
Start Date
May 21 2025
End Date
December 31 2028
Last Update
May 25 2025
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730