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NCT06699394 | RECRUITING | AL Amyloidosis

Prospective Study of Teclistamab in the Treatment of Systemic AL Amyloidosis
Sponsor:

Peking University People's Hospital

Information provided by (Responsible Party):

jin l U, MD

Brief Summary:

This study aims to evaluate the use of teclistamab in systemic AL amyloidosis and answer whether teclistamab can improve bone marrow minimal residual disease negativity. This is a single-arm, multi-center, prospective study. Participants will receive the single drug teclistamab, which the investigator deems the best choice.

Condition or disease

AL Amyloidosis

Intervention/treatment

Teclistamab (Tec)

Phase

NA

Detailed Description:

The treatment of amyloidosis should focus more on the minimal residual disease (MRD) negativity rate. We hypothesize that teclistamab can deeply eliminate cloned plasma cells in AL patients, achieving a high proportion of MRD negative rates. In clinical practice, if daratumumab, bortezomib, and venetoclax (for patients with t(11;14)）have been used, the outcome is poor. Also, MRD negativity is correlated with better clinical outcomes. In clinical routine practice, we use teclistamab, a more effective treatment to eliminate clonal plasma cells. Until now, there have been only two case series of teclistamab in systemic AL amyloidosis. To further explore efficacy and safety, we designed this prospective study.

Study Type : INTERVENTIONAL
Estimated Enrollment : 20 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Teclistamab in Systemic AL Amyloidosis: a Multi-center Prospective Study
Actual Study Start Date : 2024-12-01
Estimated Primary Completion Date : 2025-12-31
Estimated Study Completion Date : 2026-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study:
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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 bone marrow minimal residual disease (MRD) is still positive by flow cytometry;
  • 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.
Prospective Study of Teclistamab in the Treatment of Systemic AL Amyloidosis

Location Details

NCT06699394

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Locations

RECRUITING

China, Beijing

Peking University Peoples Hospital

Beijing, Beijing, China, 100044

RECRUITING

China,

Fuxing Hospital affiliated to Capital Medical University

Beijing, China,