AL Amyloidosis
Conditions
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
Interventions
Teclistamab will be administered via a subcutaneous injection
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hematologic complete response (CR) at 3 months after treatment initiation | at 3 months after treatment initiation |
Countries
China
Contacts
Primary ContactKaini Shen
Outcome results
None listed