Actively Recruiting
BCMA/CD3 Bispecific Antibody Treatment for Newly Diagnosed Amyloidosis
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2026-03-24
21
Participants Needed
1
Research Sites
116 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, single-arm, single-center clinical study designed to evaluate the efficacy and safety of low-dose BCMA/CD3 bispecific antibody (CM336) in patients newly diagnosed with systemic light chain (AL) amyloidosis.
CONDITIONS
Official Title
BCMA/CD3 Bispecific Antibody Treatment for Newly Diagnosed Amyloidosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The patient is informed of and voluntarily signs the informed consent form (ICF).
- Age 18 years or older, regardless of sex.
- Confirmed diagnosis of primary light-chain (AL) amyloidosis according to 2021 guidelines.
- Measurable disease at screening defined as difference between involved and uninvolved free light chains (dFLC) ≥50 mg/L, or serum involved free light chain ≥50 mg/L with abnormal kappa:lambda ratio.
- ECOG performance status of 2 or less.
- Adequate organ function within 3 days prior to first dose, including specific blood counts, liver enzymes, bilirubin, coagulation, and kidney function as defined.
- Male and female patients of childbearing potential and their partners must agree to use effective contraception during treatment and for at least 3 months after.
- Male patients must agree not to donate sperm from screening until 90 days after last dose.
- Willing and able to comply with all study procedures and follow-up visits.
- Women not of childbearing potential are eligible; women of childbearing potential must have a negative serum or urine β-hCG pregnancy test at screening.
- Male subjects must agree to use condoms during sexual intercourse with women of childbearing potential and have no plans to father a child from signing consent until 3 months after last dose.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
Tianjin, China, 300000
Actively Recruiting
Research Team
G
Gang An, MD
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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