Actively Recruiting

Phase Not Applicable
All Genders
NCT06699394

Prospective Study of Teclistamab in the Treatment of Systemic AL Amyloidosis

Led by Peking University People's Hospital · Updated on 2025-04-24

20

Participants Needed

2

Research Sites

91 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Prospective Study of Teclistamab in the Treatment of Systemic AL Amyloidosis

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of systemic AL amyloidosis
  • Prior treatment with daratumumab and bortezomib without achieving at least one organ response or complete hematological response
  • Life expectancy greater than 12 weeks
  • Hemoglobin level 70 g/L or higher
  • Blood oxygen saturation greater than 90%
  • Total bilirubin less than or equal to 3 times the upper limit of normal
  • Aspartate aminotransferase and alanine aminotransferase less than or equal to 3 times the upper limit of normal
  • Provided informed consent after explanation and understanding
Not Eligible

You will not qualify if you...

  • Active multiple myeloma or active lymphoplasmacytic lymphoma
  • Presence of other advanced malignant tumors with systemic metastasis
  • Severe or persistent infections that cannot be controlled effectively
  • Severe autoimmune diseases or immunodeficiency disorders
  • Active hepatitis B or hepatitis C infection
  • HIV or syphilis infection
  • Any condition that increases risk for the participant or may affect study results as judged by researchers

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Peking University Peoples Hospital

Beijing, Beijing Municipality, China, 100044

Actively Recruiting

2

Fuxing Hospital affiliated to Capital Medical University

Beijing, China

Actively Recruiting

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Research Team

Y

Yang Dr, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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