Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
30 participants
INTERVENTIONAL
2025-05-21
2028-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Teclistamab in Newly Diagnosed Mayo Stage IIIB AL Amyloidosis
NCT07079423
Prospective Study of Teclistamab in the Treatment of Systemic AL Amyloidosis
NCT06699394
A Phase II Trial of Teclistamab in Participants With Previously Treated Immunoglobulin Light-chain (AL) Amyloidosis
NCT06649695
Study Evaluating the Efficacy and Safety of CM336 Injection in the Treatment of Light-Chain Amyloidosis
NCT07039578
A Registry of Chinese AL Amyloidosis Patients Treated With Subcutaneous or Intravenous Daratumumab
NCT05277493
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Teclistamab
Teclistamab will be administered via a subcutaneous injection
Teclistamab (Tec)
Teclistamab will be administered via a subcutaneous injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Teclistamab (Tec)
Teclistamab will be administered via a subcutaneous injection
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Peking Union Medical College Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jian Li
Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Tec-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.