Using teclistamab to treat systemic 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 study evaluates the effectiveness of teclistamab in treating systemic AL amyloidosis, focusing on achieving a complete hematological response. It is a single-arm, multi-center, prospective study where participants receive teclistamab as a treatment option after failing standard therapies like daratumumab and bortezomib. The goal is to determine if teclistamab can significantly improve patient outcomes by eliminating cloned plasma cells. The study will assess both the efficacy and safety of this treatment approach.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Diagnosis of systemic AL amyloidosis;
2. Patients must have received standard-of-care daratumumab, bortezomib, they do not have at least one organ response, and have not get complete hematological response;
3. Life expectancy greater than 12 weeks;
4. HGB ≥70g/L;
5. Blood oxygen saturation \> 90%;
6. Total bilirubin (TBil) ≤3×upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0×ULN;
7. Informed consent explained to, understood by and signed by the patient.

Exclusion Criteria:

1. Fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma.
2. Presence of other tumors which is/are in advanced malignant stage and has/have systemic metastasis;
3. Severe or persistent infection that cannot be effectively controlled;
4. Presence of severe autoimmune diseases or immunodeficiency disease;
5. Patients with active hepatitis B or hepatitis C (\[HBVDNA+\] or \[HCVRNA+\]);
6. Patients with HIV infection or syphilis infection;
7. Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.

Where it's running

• Peking University Peoples Hospital
  Beijing, Beijing Municipality, China Recruiting
• Fuxing Hospital affiliated to Capital Medical University
  Beijing, China Recruiting

Study contacts

• Principal investigator: Jin Lu, M.D. — Peking University People's Hospital
• Study coordinator: Yang Dr, M.D.
• Email: pkuphliuyang@bjmu.edu.cn
• Phone: +86-10-88326542

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

• Teclistamab treatment for patients with AL Amyloidosis

  This study is testing if a new treatment called teclistamab can help people with AL Amyloidosis who haven't responded well to previous therapies.

  Recruiting Phase 2 Peking Union Medical College Hospital · Beijing, Beijing Municipality · NCT06935162

• 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.