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RECRUITINGPhase 2INTERVENTIONAL

Teclistamab in Previously Treated AL Amyloidosis

Teclistamab for Previously Treated Light-chain Amyloidosis Patients, a Phase II Study

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This is a phase II study in patients with previously treated immunoglobulin light-chain (AL) Amyloidosis to evaluate the efficacy and safety of teclistamab

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 weakened immune system 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Teclistamab (Tec)

Teclistamab will be administered via a subcutaneous injection

Locations (1)

Peking Union Medical College Hospital
Beijing, Beijing Municipality, China