Teclistamab treatment for patients with AL Amyloidosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II study evaluates the efficacy and safety of teclistamab in patients with previously treated immunoglobulin light-chain (AL) Amyloidosis. Participants must have received at least one line of treatment and show signs of relapse or insufficient response to prior therapies. The study aims to determine how well teclistamab works in this specific patient population and to assess any associated safety concerns.

Why it matters

Who can join: the full rules

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

Where it's running

• Peking Union Medical College Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Kaini Shen
• Email: shenkaini3@sina.com
• Phone: 86-13693339884

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Tec Dara for newly diagnosed multiple myeloma with light chain amyloidosis

  This study tests whether tec listamab plus daratumumab can help newly diagnosed multiple myeloma with AL amyloidosis and whether the combination is safe.

  Recruiting Phase 2 Shanghai Zhongshan Hospital · Shanghai · NCT07638683

• Teclistamab treatment for newly diagnosed Mayo stage IIIB AL amyloidosis

  This Phase II trial will test teclistamab, an immune therapy, in people with newly diagnosed Mayo stage IIIB AL amyloidosis to see if it controls disease and is safe.

  Recruiting Phase 2 Peking Union Medical College Hospital · Beijing · NCT07079423

• Using teclistamab to treat systemic AL amyloidosis

  This study is testing if teclistamab can help people with systemic AL amyloidosis who haven't responded to other treatments by seeing if it can eliminate harmful plasma cells and improve their health.

  Recruiting at 2 sites Peking University People's Hospital · Beijing, Beijing Municipality and 1 other locations · NCT06699394

• SMS text check-ins to track symptoms for people with plasma cell disorders

  This study tests whether daily SMS symptom prompts are feasible and acceptable for adults starting treatment for multiple myeloma or AL amyloidosis.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07850284

• Hungarian National Systemic Amyloidosis Registry

  This registry collects medical data from adults with systemic amyloidosis across Hungary to help understand how the disease is diagnosed and treated in real-world practice.

  Recruiting at 12 sites Semmelweis University · Balatonfüred and 11 other locations · NCT07689331

• Infliximab to Help Prevent CRS During Teclistamab or Talquetamab Therapy in Relapsed/Refractory Myeloma

  This phase 2 trial tests whether infliximab can prevent cytokine release syndrome in patients with relapsed or refractory multiple myeloma who are being treated with teclistamab or talquetamab.

  Recruiting Phase 2 Ohio State University Comprehensive Cancer Center · Columbus, Ohio · NCT07657312

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.