RecruitingNot ApplicableNCT06699394

Prospective Study of Teclistamab in the Treatment of Systemic AL Amyloidosis

Teclistamab in Systemic AL Amyloidosis: a Multi-center Prospective Study

Sponsor

Peking University People's Hospital

Enrollment

20 participants

Start Date

Mar 29, 2025

Study Type

INTERVENTIONAL

Conditions

AL Amyloidosis

Summary

This study aims to evaluate the use of teclistamab in systemic AL amyloidosis and answer whether teclistamab can improve the rate of complete hematological response. This is a single-arm, multi-center, prospective study. Participants will receive the single drug teclistamab, which the investigator deems the best choice.

Eligibility

Inclusion Criteria7

Diagnosis of systemic AL amyloidosis;
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;
Life expectancy greater than 12 weeks;
HGB ≥70g/L;
Blood oxygen saturation > 90%;
Total bilirubin (TBil) ≤3×upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0×ULN;
Informed consent explained to, understood by and signed by the patient.

Exclusion Criteria7

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

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Interventions

DRUGTeclistamab (Tec)

Teclistamab is administered subcutaneously with higher step-up doses (SUDs). Patients receive teclistamab with SUDs: 0.2 and 0.7 mg/kg and 1.5 mg/kg in Cycle 1 (2-4 days between doses). 3 mg/kg every 4 weeks will be used in subsequent cycles.