Teclistamab in Newly Diagnosed Mayo Stage IIIB AL Amyloidosis

Sponsor
Peking Union Medical College Hospital
Study ID
NCT07079423
Phase
PHASE2
Status
Recruiting
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Conditions

  • AL Amyloidosis

Eligibility Criteria

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

Interventions

  • Teclistamab (Tec) — DRUG
    Teclistamab will be administered via a subcutaneous injection

Study Details

This is a phase II study in patients with newly diagnosed Mayo stage IIIB immunoglobulin light-chain (AL) Amyloidosis to evaluate the efficacy and safety of teclistamab

Key Dates

Start date
Jun 28, 2025
Status verified
Jul 2025
Primary completion
Jan 31, 2027
Completion
Dec 31, 2027

Study Design

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

Arms

  • Experimental: Teclistamab
    Teclistamab will be administered via a subcutaneous injection

Primary Outcome Measure

Stringent difference in involved and uninvolved free light chains (dFLC) response at 1 months after treatment initiation [ Time Frame: at 1 months after treatment initiation ]

Central Contacts

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