Recruiting NCT06935162
Teclistamab in Previously Treated AL Amyloidosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Teclistamab (Tec).
- Who it may be relevant to
- Registry conditions: AL Amyloidosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Teclistamab for Previously Treated Light-chain Amyloidosis Patients, a Phase II Study
Overview
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
- Drug Teclistamab (Tec)
Teclistamab will be administered via a subcutaneous injection
Primary outcome measures
- Hematologic complete response (CR) at 3 months after treatment initiation [Time frame: at 3 months after treatment initiation]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking Union Medical College Hospital — Beijing
Identifiers
NCT: NCT06935162 · Tec-001