Prospective Study of Teclistamab in the Treatment of Systemic AL Amyloidosis

Launched by PEKING UNIVERSITY PEOPLE'S HOSPITAL · Nov 20, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called teclistamab to see if it can help patients with systemic AL amyloidosis, a condition where abnormal proteins build up in organs and tissues. The goal is to find out if teclistamab can help improve a specific condition known as minimal residual disease (MRD) in the bone marrow, which means there are still traces of the disease present even after treatment. The study is open to patients who have already received standard treatments but did not see a significant improvement.

To be eligible for this trial, participants need to have a confirmed diagnosis of systemic AL amyloidosis and have previously received treatments like daratumumab and bortezomib without seeing a major response. Other criteria include having a good life expectancy and satisfactory blood tests. If you join the study, you will receive teclistamab and will be monitored closely by healthcare professionals. This trial is currently recruiting participants of all ages and genders, aiming to provide more effective treatment options for this challenging condition.

Gender

ALL

Eligibility criteria

• 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.