Prospective Study of Teclistamab in the Treatment of Systemic AL Amyloidosis

Sponsor
Peking University People's Hospital
Study ID
NCT06699394
Status
Recruiting
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Conditions

  • AL Amyloidosis

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Teclistamab (Tec) — DRUG
    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.

Study Details

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.

Key Dates

Start date
Mar 29, 2025
Status verified
Apr 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Group 1
    Teclistamab monotherapy

Primary Outcome Measure

Complete hematological response [ Time Frame: 3 months, 6 months ]

Central Contacts

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